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Get FDA 3500A 2019-2024

Identify each report as device 1 device 2 etc. Form FDA 3500A for each different suspect device. Each 3500A will be given a separate Manufacturer Report Number. If the event involves more than one suspect medical device complete all applicable sections of Form FDA 3500A for the first device and a separate section D Suspect Medical Device and Blocks F9 F10 F13 and F14 for each additional device. Print Next Page Reset Form U.S. Department of Health and Human Services Food and Drug Administration For use by user-facilities importers distributors and manufacturers for MANDATORY reporting MEDWATCH General Instructions FORM FDA 3500A 1/09 A. The following specific information is to be incorporated Include the phrase continued at the end of each field of FDA Form 3500A that has additional information continued onto another page Section G All manufacturers may be substituted for section D Suspect medical device on the front of the form to enable the submission of a one page form If section G is reproduced on the front of the form it must be an identical reproduction of the original section G All submissions must be made in English including foreign literature reports. Identify all attached pages as Page of Indicate the appropriate section and block number next to the narrative continuation Display the User Facility Distributor Importer or Manufacturer report number in the upper right corner as applicable Include the firm s or facility s name in the upper right corner as well if the report is from a user facility distributor importer or manufacturer If no suspect medical device is involved in a reported adverse event i.e. when reporting ONLY a suspect drug or biologic ONLY sections A B C E and G are to be filled out FRONT PAGE At the top of the front page If the case report involves more than two 2 suspect medications attach another copy of Form FDA 3500A with only section C or section D filled in as appropriate. PATIENT INFORMATION 1. Patient Identifier Adverse Event and/or lbs or Male B. ADVERSE EVENT OR PRODUCT PROBLEM FDA Use Only Section C - Help 1. Name Give labeled strength mfr/labeler 4. Weight Female Date of Birth UF/Importer Report C. SUSPECT PRODUCT S 3. Sex Mfr Report Page 1 of 15 2. Age at Time of Event In confidence Form Approved OMB No* 09 10-029 1 Expires 12/31/11 See OMB statement on reverse. kgs 2. Dose Frequency Route Used 3. Therapy Dates If unknown give duration from/to or best estimate Product Problem e*g* defects/malfunctions 2. Outcomes Attributed to Adverse Event Check all that apply Death 5. Event Abated After Use Stopped or Dose Reduced Doesn t Yes No Apply 4. Diagnosis for Use Indication Disability or Permanent Damage mm/dd/yyyy Life-threatening Congenital Anomaly/Birth Defect Hospitalization - initial or prolonged Other Serious Important Medical Events 8. Event Reappeared After Reintroduction Required Intervention to Prevent Permanent Impairment/Damage Devices 3. Date of Event mm/dd/yyyy 4. Date of This Report mm/dd/yyyy 5. Describe Event or Problem 7. Exp* Date 6.

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