FDA FORM 3500A PDF

Founded in , the MedWatch program was established by the FDA to help collect data on adverse events in the healthcare industry. Adverse events range in severity between mild and lethal, but the term is generally used to describe any event that is undesirable in connection with the use of a specific medical device or product. The MedWatch form, also known as Form FDA A , is used for mandatory reporting of medical device adverse events by manufacturers, user facilities and importers. Form FDA , a condensed version of A, is used for voluntary reporting of adverse events by healthcare professionals, consumers and patients.

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Required medical or surgical intervention to prevent permanent impairment or damage Devices Other Serious Important Medical Events Please see instructions for block B2 for further information on each of these criteria. Product problem e.

In addition, please select this category when reporting device malfunctions that could lead to a death or serious injury if the malfunction were to recur. Also report circumstances or events that have the capacity to cause error e. Product use errors can and do originate in all stages of the medication use system, which includes selecting and procuring drugs, prescribing, preparing and dispensing, administering and monitoring. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labeling, packaging, nomenclature, compounding, dispensing, distribution, administration, education, monitoring and use.

These problems can arise due to problems with the design of the medical device or the manner in which the device is used. Please report device use errors regardless of patient involvement or outcome. Also report circumstances of use or device interactions that could cause or lead to use errors. If you have returned to your prior medication, please note if the prior therapeutic response has returned. Do not check if: The patient died while using a medical product, but there was no suspected association between the death and the use of the product.

A fetus is aborted because of a congenital anomaly birth defect , or is miscarried. Life-threatening: Check if you suspect that: The patient was at substantial risk of dying at the time of the adverse event, or Use or continued use of the device or other medical product might have resulted in the death of the patient.

Hospitalization initial or prolonged : Check if admission to the hospital or prolongation of hospitalization was a result of the adverse event. Do not check if: A patient in the hospital received a medical product and subsequently developed an otherwise non-serious adverse event, unless the adverse event prolonged the hospital stay. Do check if: A patient is admitted to the hospital for one or more days, even if released on the same day. An emergency room visit results in admission to the hospital.

Emergency room visits that do not result in admission to the hospital should be evaluated for one of the other serious outcomes [e. Required Intervention to Prevent Permanent Impairment or Damage: Check if you believe that medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product.

The development of drug dependence or drug abuse would also be examples of important medical events. If day is unknown, month and year are acceptable. If day and month are unknown, year is acceptable. When a newborn baby is found to have a congenital anomaly, the event onset date is the date of birth of the child. When a fetus is aborted because of a congenital anomaly, or is miscarried, the event onset date is the date pregnancy is terminated. If information is available as to time during pregnancy when exposure occurred, indicate that information in narrative block B5.

If available and if relevant, include synopses of any office visit notes or the hospital discharge summary. To save time and space and if permitted by your institution , please attach copies of these records with any confidential information deleted.

Do not identify any patient, physician, or institution by name. Information as to any environmental conditions that may have influenced the event should be included, particularly when but not exclusive to reporting about a device.

Results of relevant tests and laboratory data should be entered in block B6. See instructions for B6. Preexisting medical conditions and other relevant history belong in block B7. Be as complete as possible, including time courses for preexisting diagnoses see instructions for B7.

If it is determined that reuse of a medical device labeled for single use might have caused or contributed to an adverse patient outcome, please report in block B5 the facts of the incident and the perceived contribution of reuse to the occurrence. For adverse events occurring in donors of whole blood or blood components, please indicate that the adverse event occurred in a donor and the procedure for donation e. For a product problem: Describe the problem quality, performance, or safety concern in sufficient detail so that the circumstances surrounding the defect or malfunction of the medical product can be understood.

For a product use error: see B1 above : Describe the sequence of events leading up to the error in sufficient detail so that the circumstances surrounding the error can be understood. For Medication Use Errors: Include a description of the error, the type of staff involved, the work environment in which the error occurred, indicate causes or contributing factors to the error, location of the error, names of the products involved including the trade proprietary and established proper name, manufacturer, dosage form, strength, concentration, and type and size of container.

For Medical Device Use Errors: Include a description of the device use error, the type of staff involved, the work environment in which the error occurred, and the circumstances or events that led to or contributed to the use errors. Please include: Any relevant baseline laboratory data prior to the administration or use of the medical product.

All laboratory data used in diagnosing the event. If available, please include: Any pre- and post-event medication levels and dates if applicable.

Synopses of any relevant autopsy, pathology, engineering, or lab reports. If preferred, copies of any reports may be submitted as attachments, with all confidential information deleted. Do not identify any patient, physician or institution by name.

For example, if available, provide information on: Other known conditions in the patient, e.

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