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Get FDA 3500A 2009

Orm FDA USE ONLY MEDWATCH FORM FDA 3500A (1/09) (continued) Section F - Help Page 2 of 15 F. FOR USE BY USER FACILITY/IMPORTER (Devices Only) 1. Check One 2. UF/Importer Report Number Importer User Facility Section H - Help H. DEVICE MANUFACTURERS ONLY 1. Type of Reportable Event 3. User Facility or Importer Name/Address 2. If Follow-up, What Type? Death Correction Serious Injury Additional Information Malfunction Response to FDA Request Other: Device Evaluation 3. Device Eval.

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