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FDAAdverse Event
[INTEGRA - PRINCETON] DURAGEN 3X3 1 PACK CE — Injury
Jan 16, 2026
Date Received: 20260116Captured: 2026-03-01INTEGRA - PRINCETONDevice: DURAL REPAIRProduct Code: GXQ
Device: DURAL REPAIR | Patient outcome(s): Other | [Additional Manufacturer Narrative] AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. | [Description of Event or Problem] A FACILITY REPORTED THAT ID...
- •Agency: FDA
- •Type: adverse_event
- •Source available
Event Description
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Report Type:['Initial submission']
Source Type:['Foreign', 'Health Professional', 'User facility', 'Company representation']
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