MalfunctionOJJ
REGARD
Received Feb 22, 2024
Report 3014527682-2024-00009 · MDR key 18759620
Device
Generic name
Burn Pack
Manufacturer
Roi Cps, LlcModel number
GS00082YCatalog number
880082025
Lot number
98196
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
A SITE VISIT TO THE FACILITY WHO REPORTED THIS EVENT WAS CONDUCTED BY OUR FIRM. ROI CPS, LLC KITS WERE OBSERVED FROM RECEIVING THROUGH HANDLING, STORAGE, AND USE OF THE KITS AT THE USER FACILITY, WITH FACILITY STAFF PRESENT. THE CONCULSIONS DRAWN AND STORAGE AND HANDLING RECOMMENDATIONS TO THE FACILITY ARE ATTACHED TO THIS REPORT FOR REFERENCE.
Description of Event or Problem
LARGE TEAR NOTED IN THE VENTED BAG BEFORE OPENING FOR CASE.