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Click ‘Get Form’ to open the MedWatch Form 3500 in the editor.
Begin by filling out Section A, Patient Information. Enter the patient identifier, age or date of birth, gender, weight, ethnicity, and race as applicable.
Proceed to Section B for Adverse Event or Product Problem. Select the type of report and describe the event in detail in block B5.
In Section C, list any suspect products involved. Provide their names, strengths, and manufacturers in block C1.
Complete Section D if a medical device is involved. Include details such as brand name and model number.
Finally, review all sections for accuracy before submitting your completed form through our platform.

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Versions	Form popularity	Fillable & printable
2022	4.2 Satisfied (31 Votes)
2019	4.9 Satisfied (52 Votes)
2015	4.8 Satisfied (50 Votes)
2009	4.3 Satisfied (55 Votes)
2003	4.9 Satisfied (49 Votes)

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What should I not report to MedWatch?

Patients should not report com- mon, less serious adverse events cited in the prescribing information, such as nausea or constipation, to MedWatch. In addition, patients should not report problems associated with vaccines, investigational drugs or biologics, or websites selling illegal products.

What is a MedWatch Form 3500?

The MedWatch form, also known as Form FDA 3500A, is used for mandatory reporting of medical device adverse events by manufacturers, user facilities and importers. Form FDA 3500, a condensed version of 3500A, is used for voluntary reporting of adverse events by healthcare professionals, consumers and patients.

What is Form 3500 to the FDA?

Form FDA 3500 may be used by health professionals or consumers for VOLUNTARY reporting of adverse events, product use/medication errors, product quality problems, and therapeutic failures for: Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers.

medwatch form 3500a

Medwatch form 3500 template Medwatch form 3500 sample Medwatch form 3500 instructions Medwatch form 3500 online Medwatch form 3500 pdf FDA Form 3500A pdf FDA Form 3500 vs 3500A MedWatch form 3500B

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What should be reported to MedWatch?

MedWatch is FDAs program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors associated with FDA-regulated products.

What should be reported to MedWatch?

MedWatch is FDAs program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors associated with FDA-regulated products.

What should I not report to MedWatch?

Patients should not report com- mon, less serious adverse events cited in the prescribing information, such as nausea or constipation, to MedWatch. In addition, patients should not report problems associated with vaccines, investigational drugs or biologics, or websites selling illegal products.

What gets reported to MedWatch?

MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products such as: Prescription and over-the-counter medicines. Biologics such as blood components, blood/plasma derivatives and gene therapies. Medical devices such as hearing aids breast pumps, and pacemakers.

What are the reporting requirements ing to the FDA for the hospital?

User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.

Medwatch form 3500-2025

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