evaluation of unanticipated adverse device effects (uades) must be reported to the fda by the:

Answers

Answer 1

In event of the evaluation of unanticipated adverse device effects, they must be reported to the FDA by the sponsor.

What is the FDA?

The FDA is the acronym for the Food and Drug  Administration. This agency is in charge of the process of production and approval of foods and drugs in the United States.

In event of the evaluation of unanticipated adverse device effects, they must be reported to the FDA by the sponsor.

Learn more about FDA:https://brainly.com/question/9072310

#SPJ11


Related Questions

Making healthful food choices includes the following: Making healthful food choices includes the following: Make half of your grains whole. All of the above. Focus on fruits. Get calcium rich foods. Vary your vegetables.

Answers

Making a healthful food choice includes all of the above-given options.

What is a healthful food choice?

A healthful food choice is a balanced and nutritional food diet that consists of all classes of food. A healthy food choice contains:

Fruits and vegetablesWhole grainsLow-fat milk products, andCalcium-rich foods.

A healthy food choice is devoid of saturated fats. It is recommended to eat a healthful food choice in order to maintain good nutritional health conditions.

Learn more about healthful food choices here:

https://brainly.com/question/10162449

#SPJ12

what is the purpose of obtaning a 12-lead electrocardiogram early during the post-cardiac arrest care phase

Answers

The purpose of obtaining a 12-lead electrocardiogram early during the post-cardiac arrest care phase is to identify those patients with ST-segment myocardial infarction.

What is myocardial infarction?

Myocardial infarction is defined as the type of heart attack that occurs due to failure of proper distribution of oxygen and blood to the heart muscles due to blockage of the Coronary blood vessels.

An electrocardiogram can be used to monitor the treatment and management of myocardial infarction.

Therefore, the purpose of obtaining a 12-lead electrocardiogram early during the post-cardiac arrest care phase is to identify those patients with ST-segment myocardial infarction.

Learn more about electrocardiogram here:

https://brainly.com/question/7172728

#SPJ1

What imaging modality uses the unit of measurement known as the bq?

Answers

The imaging modality uses the unit of measurement known as the bq is nuclear medicine.

What is nuclear medicine?

Nuclear medicine is an aspect of medicine that involve the use of radiology and radioactive elements to to assess and examine organs in the body plus their structures and their roles.

Therefore, The imaging modality uses the unit of measurement known as the bq is nuclear medicine.

Learn more about nuclear medicine below

https://brainly.com/question/7991938

#SPJ12

which behavior indicates a client has entered the second stage of labor restless thrashing about

Answers

The behaviour that indicates that client has enter the second stage of labor is Complaints of sudden, intense back pain which may occur with persistent posterior pressure.

What is labor?

A pregnant woman is said to be in labor when such starts experiencing series of physiological contractions that will eventually lead to child birth.

The various stages of labor include:

First stage: This is when the neck of the womb (cervix) opens to 10cm dilated.

Second stage: This is when the baby moves down through the vagina and is born.

The behaviour that indicates that client has enter the second stage of labor is Complaints of sudden, intense back pain which may occur with persistent posterior pressure leading to the birth of the baby.

Learn more about pregnancy stages here:

https://brainly.com/question/15047039

#SPJ1

Antitussives and antidiarrheals that contain small amounts of opioids, such as codeine, belong to which schedule of controlled substances?.

Answers

Answer:

Schedule V drugs are generally used for antidiarrheal, antitussive, and analgesic purposes.

Explanation:

Carrie is a new medical assistant who is assisting for the first time as a floater for a minor surgical procedure. The physician removes tissue from the incision and asks carrie for the container in which to place the specimen for laboratory examination. Carrie grasps the specimen container and reaches across the tray so the physician can place the specimen in the container. What did carrie do wrong?.

Answers

Carrie is doing wrong as she should not have arrived across the tray with all the necessary equipment.

What is Surgical Procedure?

A surgical procedure may be characterized as a medical approach implicating an incision with tools that are accomplished to overhaul deterioration or arrest illness in a living body.

Carrie is a new medical assistant who does not have much experience in the field of medical procedures. While performing a minor surgical procedure she must require to arrive at the site of action across the tray with all sterilized medical equipment.

Therefore, it is well described above.

To learn more about Medical Procedures, refer to the link:

https://brainly.com/question/23980400

#SPJ1

A decrease in the autonomic tone of the smooth muscle in a blood vessel would result in.

Answers

A decrease in the autonomic tone of the smooth muscle in a blood vessel would result in an increase in the blood flow of these vessels.

What is smooth muscle?

The smooth muscle is a type of muscle tissue that act via involuntary impulses to contract in rhythmic sequences.

The smooth muscle is the muscle tissue that forms the walls of blood vessels and acts by contracting them.

The autonomic nervous system is able to promote contraction/relaxation cycles of the smooth muscle tissue.

In conclusion, a decrease in the autonomic smooth muscle activity generates an increase in the blood flow of blood vessels.

Learn more about smooth muscle here:

https://brainly.com/question/1443137

#SPJ1

A 25-year-old client receives a knife wound to the leg in a hunting accident. Which type of immunity was compromised

Answers

In the given scenario, the client will probably receive natural immunity, i.e., option b.

What is natural immunity?

Natural immunity occurs when you are infected by a germ and the immune system responds by producing antibodies against it.

The missing options are:

a. Passive immunityb. Natural immunityc. Adaptive immunityd. Specific immunity

In the given scenario, a 25-year-old client receives a knife wound to the leg in a hunting accident which will lead to development of natural immunity in client.

Thus, the correct option is b.

For more details regarding natural immunity, visit:

https://brainly.com/question/13778292

#SPJ1

Mr. Sinclair has diabetes and heart trouble and is generally satisfied with the care he has received under Original Medicare, but he would like to know more about Medicare Advantage Special Needs Plans (SNPs). What could you tell him

Answers

Mr. Sinclair needs the Special Needs Plan because it includes special care for patients with chronic conditions as he does have.

What is Medicare?

Medicare is the health insurance scheme that is provided by the Government of the United States of America and covers only citizens who are 65 yeas old and above.

Mr. Sinclair needs the Special Needs Plan because it includes special care for patients with chronic conditions as he does have.

Learn  more about Medicare:https://brainly.com/question/14011571?

#SPJ12

Answer: SNPs have special programs for enrollees with chronic conditions, like Mr. Sinclair, and they provide prescription drug coverage that could be very helpful as well.

Explanation:

The goal in FitnessGram is for children to achieve the _____________________ on as many assessments as possible.

Answers

The goal in FitnessGram is for children to achieve the healthy fitness zone on as many assessments as possible.

What is fitness?

It should be noted that fitness means the ability to execute the daily activities with optimal performance.

Here, the goal in FitnessGram is for children to achieve the healthy fitness zone on as many assessments as possible.

Learn more about fitness on:

brainly.com/question/1762633

#SPJ12

A conversion factor is multiplied by a _________ to arrive at a charge.

Answers

A conversion factor is multiplied by a relative value unit to arrive at a charge.

What is a Conversion Factor in Medical Dosage Calculation?

A conversion factor is a number that is used to convert one set of units into another either by dividing or multiplying them. When converting to an equivalent value, the proper conversion factor must be utilized.

So let's assume we want to convert from kilogram to pounds; we need to use the proper conversion factor from standard dimension analysis.

Therefore, a conversion factor is multiplied by a relative value unit to arrive at a charge.

Learn more about conversion factors here:

https://brainly.com/question/16814684

#SPJ11

Mr. Singh would like drug coverage but does not want to be enrolled in a medicare advantage plan. What should you tell him?.

Answers

Mr. Singh can enroll in a stand-alone prescription drug plan while maintaining Part A and Part B coverage through Original Fee-for-Service Medicare. The correct option is c.

What is drug coverage?

Health insurance or a plan that assists in the payment of prescription drugs and medications. Prescription drugs are covered by all Marketplace plans.

The missing options are:

a. Part D prescription drug coverage can only be obtained by enrollment into a Medicare Health Plan that also covers Part A and Part B services.b. Mr. Singh must leave Original Medicare to receive drug coverage.c. Mr. Singh can enroll in a stand-alone prescription drug plan and continue to be covered for Part A and Part B services through Original Fee-for-Service Medicare.d. Mr. Singh will have to enroll in Medicaid if he wishes to obtain prescription drug coverage through some means other than a Medicare Health Plan.

Mr. Singh can enroll in a stand-alone prescription drug plan while maintaining Part A and Part B coverage through Original Fee-for-Service Medicare.

Thus, the correct option is c.

For more details regarding drug coverage, visit:

https://brainly.com/question/13009409

#SPJ1

The type of stretching in which a person performs a movement and holds it for a set amount of time is called

Answers

Active stretching, or static active stretching.

A client is admitted for a transurethral resection of the prostate (TURP). Preoperative teaching will include which information

Answers

Preoperative teaching will include the epidural or spinal anesthesia which will be administered to the patient.

What is preoperative teaching?

It should be noted that preoperative teaching is the program of instruction that should be based on one's learning needs.

In this case, preoperative teaching will include the epidural or spinal anesthesia which will be administered to the patient.

Learn more about teaching on:

brainly.com/question/14949548

#SPJ12

A breastfeeding mother is worried that her baby will develop food allergies if she eats peanuts or tree nuts before breastfeeding. Food allergies do not develop after breastfeeding, but they do develop if the infant is formula fed. Current evidence regarding breastfeeding and food allergies states that

Answers

Current evidence regarding breastfeeding and food allergies states that dietary restrictions will not prevent or delay food allergies in infants.

What is a Food allergy?

A Food allergy may be defined as a circumstance when the body's immune system responds unusually to distinctive foods and causes some abnormal reactions in the body.

There must be a possibility of food allergy in infants due to breastfeeding. So, it is required for the mothers to take normal foodstuffs during the time of breastfeeding.

This is also because dietary regulations and limitations will not control or hinder certain types of food allergies in infants majorly.

Therefore, it is well described above.

To learn more about Food allergies, refer to the link:

https://brainly.com/question/26902895

#SPJ1

In theory, what would be the approximate weight gain of a person who consumes an excess of 500 kcal every day for four weeks (e.g., about 28 days)

Answers

A person who consumes an excess of 500 kcal every day for four weeks, he gains 4 pounds weight.

How much weight a person will gain?

Studies suggested that an increase of 500 kcal each day will promote a one pound weight gain per week. So if a person consumes 500 kcal for 4 weeks i.e. 28 days, so the person gains about 4 pounds of weight.

So we can conclude that a person who consumes an excess of 500 kcal every day for four weeks, he gains 4 pounds weight.

Learn more about weight here: https://brainly.com/question/2337612

#SPJ12

A health information manager took the three elements, blood pressure, weight, and cholesterol to analyze for potential indicators of a heart attack. The combined data is referred to as?

Answers

The data that the information manager took can be considered as information.

What is the information?

Information is a set of data that has the characteristic of being organized for its understanding and that has the objective of transmitting a message to a specific recipient.

According to the above, the information manager organizes this data to allow doctors to have the data organized so that they can read it and deduce which patient has heart attack symptoms.

Learn more about information in: https://brainly.com/question/13629038

#SPJ12

A 14-year-old girl presents to her primary care provider with a 3-to-4-month history of abdominal pain. Several mornings each week, the patient awakens with epigastric and periumbilical pain, and she does not want to eat breakfast. Eating makes her pain worse, and she does have some nausea. She does not have diarrhea, constipation, or blood in her stool. She has not gained weight since her last visit 6 months ago. On physical examination, she is a healthy-appearing, Tanner Stage IV adolescent whose weight and height are at the 50th percentile for age. Her abdomen is soft but mildly tender throughout. There is no perianal disease, and the stool in her rectum is hemoccult negative. You suspect that she has functional abdominal pain (functional dyspepsia). Which of these tests would be helpful to obtain to exclude other likely causes of her pain

Answers

The test that would be useful to rule out other likely causes of your pain would be Upper Endoscopy with no injuries to the stomach or duodenum that could be responsible for the symptoms.

What is Functional Dyspepsia?

Functional dyspepsia is a gastric disorder characterized by the presence of one or more symptoms (epigastric pain, postprandial fullness, early satiety, stomach burning) during the last 3 months and that started at least 6 months before.

With this information, we can conclude that the test that would be useful to rule out other likely causes of your pain would be Upper Endoscopy with no injuries to the stomach or duodenum that could be responsible for the symptoms.

Learn more about Functional dyspepsia in brainly.com/question/905805

#SPJ11

Using your ICD-10-CM code book look for the diagnosis code for a patient with a preoperative diagnosis of abdominal pain, right lower quadrant and a postoperative diagnosis of acute appendicitis with peritoneal abscess. What ICD-10-CM coding is reported

Answers

Postoperative diagnosis of acute appendicitis with peritoneal abscess is ICD 10 K35.

What is the ICD 10?

ICD-10 LIST - The International Classification of Diseases and Related Health Problems (also known as the International Classification of Diseases - ICD 10) is published by the World Health Organization (WHO) and aims to standardize the coding of diseases and other health-related problems .

With this information, we can conclude that postoperative diagnosis of acute appendicitis with peritoneal abscess is ICD 10 K35.

Learn more about ICD-10 in brainly.com/question/14819864

#SPJ11

According to the article, how and why dos personality change later in life?

Answers

Answer:

Personality, one's characteristic way of feeling, behaving and thinking, is often conceptualized as a person's standing on each Big Five personality trait (extraversion, neuroticism, openness to experience, agreeableness and conscientiousness).

A person's personality profile is thus gauged from their standing on five broad concepts which predict, among other life outcomes, behavior and the quality of interpersonal relationships. Initially, it was believed that one's Big Five profile was static and dichotomous in that one was either at one extreme of each trait or another .For example, people are typically categorized as introverted or extraverted.

Change over a lifetime

There are two very specific types of change that researchers tend to focus on: rank-order change and mean-level change. A rank-order change refers to a change in an individual's personality trait relative to other individuals; such changes do not occur very often. A mean-level change refers to an absolute change in the individual's level of a certain trait over time. Longitudinal research shows that mean-level change does occur.However, some traits tend to change while some traits tend to stay stable.

There is an increase in consistency of a trait as age increases. However, personality does not stop changing at a specific age. Biological and social transitions in life may also be a factor for change. Biological transitions are stages like puberty or first childbirth. Social transitions might be changes in social roles like becoming a parent or working at a first job. These life transitions do not necessarily cause change, but they may be reasons for change.

One theory says that whether or not these life transitions cause personality change is based on whether the transition was expected based on age or was unforeseen.The events that are expected will cause personality change because those events have common scripts. However, events that are unexpected will give prominence to the traits that already exist for the individual.Historical context also affects personality change. Major life events can lead to changes in personality that can persist for more than a decade.

Stressful life events

Negative life events,long-term difficulties,and deteriorated life quality, all predict small but persistent increases in neuroticism, while positive life events, and improved life quality, predict small but persistent decreases in neuroticism. There appears to be no point during the lifespan that neuroticism is immutable,which is known as the plasticity principle.

Mechanisms of change

There are multiple ways for an individual's personality to change. Individuals will change their behavior based on the ideas in their environment that emit rewards and punishments. Some of these ideas might be implicit, like social roles.

The individual changes his or her personality to fit into a social role if it is favorable.  An individual may decide to actively try to change his or her own behavior/ personality after thinking about his or her own actions.

Personality change also occurs when individuals observe the actions of others. Individuals may mimic the behaviors of others and then internalize those behaviors. Once the individual internalizes those behaviors they are said to be a part of that person's personality.

Individuals also receive feedback from other individuals or groups about their own personality. This is a driving force of change because the individual has social motivations to change his or her personality.  It has also been shown that major positive and negative life events can predict changes in personality.

I hope this helps you.

Please mark me as brainlist.

You are providing high-quality CPR on a 6-year-old patient who weighs 44 pounds. The AED arrives. It does not have a pediatric setting and includes only adult AED pads. What should you do

Answers

You are providing high-quality CPR on a 6-year-old patient who weighs 44 pounds. The adult AED cannot be used.

Can you use adult AEDs on children?

The AED Defibrillator works through self-adhesive electrodes that are attached to the patient's chest and these electrodes are available in adult and child models. The children's models can be used in children from 4 to 25 kg, that is, from babies of approximately 2 months to children of 8 years old.

With this information, we can conclude that you are providing high-quality CPR on a 6-year-old patient who weighs 44 pounds. The adult AED can be used because the child's AED is for children under 4 years old.

Learn more about AED in brainly.com/question/4652770

#SPJ11

Mr. Wu is eligible for medicare. He has limited financial resources but failed to qualify for the part d low-income subsidy. Where might he turn for help with his prescription drug costs?.

Answers

Mr. Wu should turn to the State Pharmaceutical Assistance Program for help since he is eligible for Medicare.

What is a health care plan?

A health care plan can be defined as a medical plan or an insurance for the medical care of a particular patient which covers a part or whole risk of the medical expenses incurred such as Medicare.

In this scenario, Mr. Wu should turn to the State Pharmaceutical Assistance Program for help since he is eligible for Medicare because he may still qualify for help in paying Part D low-income costs.

Read more on Medicare here: https://brainly.com/question/14166257

#SPJ1

Answer: His State Pharmaceutical Assistance Program

Explanation:

Give patient 500 mg of dopamine in 250 mL of D5W to infuse at 20 mg/hr. Calculate the flow rate in mL/hr.

Answers

The flow rate in mL/hr is 10.

What is Infusion?

An infusion may be defined as a process of being extracted some compounds from original products.

The flow rate is calculated as:

Amount of dose given to patient per hour = 20mg/hr.

Total concentration of dose = 500mg.

Total volume in mL = 250mL.

Flow rate = Amount of dose given to patient per hour/Total concentration of dose × Total volume in mL.

            = [tex]\frac{20 mg/hr}{500 mg} * 250[/tex] = 10mL/hr.

Therefore, The flow rate in mL/hr is 10.

To learn more about Dopamine, refer to the link:

https://brainly.com/question/904533

#SPJ1

Assume you have been asked to collect data on health problems facing a remote community
which is still primitive and has strong traditional beliefs. Explain potential obstacles that might be
experienced and how they can be addressed

Answers

The obstacle of language barrier and distrust when collecting dat can be overcome by using a trusted member of the community as an interpreter and showing respect for their beliefs and customs.

What is data collection?

Data collection refers to the process of gathering data about a particular subject or topic

Data gathering is essential in health care as it provides information on which how beat to handle health care delivery.

One of the challenges will be language and communication barrier.

Another challenge is convincing the people to trust you.

The best way to handle the first obstacle will be to go through a trusted member of the community as an interpreter.

The second obstacle will be to show them concern and respect their culture and beliefs.

Therefore, the obstacle of language barrier and distrust when collecting dat can be overcome by using a trusted member of the community as an interpreter and showing respect for their beliefs and customs.

Learn more about data collection at: https://brainly.com/question/25633523

#SPJ1

A prescriber orders clonidine ER (Kapvay ER) tablets for a 12-year-old child to treat which condition

Answers

Clonidine ER (Kapvay ER) tablets are used for a 12-year-old child to treat hypertension condition.

What is the effect of clonidine ER (Kapvay ER) tablets?

Kapvay is a type of medication which is used to treat hypertension. It may also reduce attention deficit hyperactivity disorder (ADHD) in children ages 6-12.

So we can conclude that clonidine ER (Kapvay ER) tablets are used for a 12-year-old child to treat hypertension condition.

Learn more about hypertension here: https://brainly.com/question/26093747

#SPJ12

The laboratory test that measure the percentage by volume of packed red blood cells in a whole blood sample is known as a/an test.

Answers

Answer:

A hematocrit (he-MAT-uh-krit) test

when caring for a client who has pancytopenia after treatment for hodgkin disease, which assessmnet

Answers

Drugs to stimulate blood cell production in your bone marrow should be included in the patient's care plan.

What is pancytopenia?

Pancytopenia is a condition in which there is a lower-than-normal number of red and white blood cells and platelets in the blood.

When caring for a client who has pancytopenia after treatment for hodgkin disease, drugs to stimulate blood cell production in your bone marrow should be included in the patient's care plan.

Learn more about pancytopenia here: https://brainly.com/question/14517447

#SPJ12

What would be an example of a cultural difference that may affect one's health? Multiple choice question. family values personal preferences genetic predispositions

Answers

Family values is an example of a cultural difference that may affect one's health.

How culture affected one's health?

Family and Community retain certain beliefs as a result of these beliefs the health of an individual can be affected. Some beliefs have negative impacts on the health because they are hazardous to our health.

So we can conclude that family values is an example of a cultural difference that may affect one's health.

Learn more about culture here: https://brainly.com/question/25010777

#SPJ12

The only direct connection between the pectoral girdle and the axial skeleton is where the.

Answers

it is the clavicle bone...............

which position would help the client who has an above-the-knee amputation prevent a contracture

Answers

A prone position every 3 to 4 hours for 20 to 30 minutes periods.

What does amputation mean and what are the different types of amputation?

The lessening by surgery of a limb (arm or leg) or another body part because of damage or disease, such as diabetes or cancer.

Above-knee amputationBelow-knee amputation.Arm amputation.Hand amputation.Finger amputation.

Thus, this could be the answer.

To learn more about  amputation click here:

https://brainly.com/question/9580609

#SPJ1

Other Questions
ALBERTO: Tami, Ive got a problem. Can we talk for a minute?TAMI: Sure, Alberto, whats up?ALBERTO: Last week my sous-chef, Ricky, bought tomatoes that just werent ripe. It made me really angry. Well never keep our Michelin star unless we maintain the quality of our produce!TAMI: Wow, Alberto, that sounds like a real problem. So youre saying that Ricky bought tomatoes you couldnt serve?ALBERTO: Yes! And its not the first time...TAMI: Ill do something about this right away.What component of reflective listening is missing from this conversation? Affirming contact Clarifying the implicit Paraphrasing the expressed 12, 3.1.52If f(x) = x and g(x) = 2x, find f[g(x)], and g[f(x)] How does Macbeth feel about Duncan's plans for his son? The President's conversations in the ______________ were recorded. Watergate Hotel Oval Office Lincoln Memorial Democratic National Convention Washington Monument 2. Choose the best answer. The Supreme Court recognized that Hispanics were often treated as a recognized ___. race institution class tribe If a-4b=18,what is 3a/81b Which of the following is equivalent to Which pair of equations below represents two lines that are not parallel?Select one:a.y = 2x + 8 and y = 2x + 8b.y = ( 1 / 6 ) x + 1 /2 and y = (1 / 6 ) x + 2c.y = ( 1 / 6 ) x + 8 and y = 6x + 4d.y = ( 1 / 2 ) x + 9 and y = ( 1 / 2) x + 4 A 3-gallon bucket of paint costs $108.60. What is the price per quart? What is the units digit of the sum 1! + 2! + 3! + 4! + 5! + ... + 1000!?please help if you can Populist believed that bankers, land owners, and political parties Please help fast!! Multiply and reduce to lowest terms. Convert into a mixed number if necessary. [tex]3 \times \frac{2}{5} [/tex] Please help! Which choice belongs in space number 3? The first five terms of a quadratic sequence is 1,8,21,40,65 . What is the nth term of this sequence? Thanks And will give a brainliest!! The selective thickness shims are measured with a(n): Group of answer choices hydraulic press. outside micrometer. dial indicator. depth micrometer. Discuss the importance of chemical reaction in our daily life? I think my other question might've been deleted for some reason By 2050, the world population is expected to reach __________ billion people. a. 4 b. 6 c. 9 d. 12 How are the games used to maintain control over the districts? conversely, how are the games used to keep the capitol happy and content? The half-life of Iodine-131 is 8.0252 days. If 14.2 grams of I-131 is released in Japan and takes 31.8 days to travel across the Pacific, how much I-131 will be left by the time it reaches California? Identify a true statement about modern managers in Western society They view their task as one of motivating employees to do their best They are of the view that the practice of threatening employees is usually productive They function as enforcers and disciplinarians They believe that trust and respect should be demanded