DR COMFORT
Received Sep 24, 2024 · Event occurred Aug 8, 2024
Report 3008579854-2024-00005 · MDR key 20297408
Device
Generic name
Fisherman Chestnut 12 Wide
Manufacturer
Dr Comfort; A Djo, Llc CompanyCatalog number
9820-W-12.0
Lot number
UNKNOWN
Product problems
- Material Twisted/Bent
- Patient Device Interaction Problem
- Material Twisted/Bent
- Patient Device Interaction Problem
Patient
NA · Unknown
- Ulcer
- Tissue Breakdown
- Ulcer
- Tissue Breakdown
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT RIGHT HEEL COUNTER FOLDING CAUSING ULCER ON BACK OF HEEL CLINICIAN UNABLE TO SMOOTH MATERIAL CAUSING SWELLING. THE RETURNED PRODUCT WAS EVALUATED, AND THE ISSUE HAS BEEN CONFIRMED AS REPORTED DUE TO HEEL COUNTER ISSUE ROOT CAUSE COULD NOT BE ESTABLISHED. THE ROOT CAUSE IS TRACED BACK TO A MANUFACTURING DEFECT. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.
Description of Event or Problem
IT WAS REPORTED THAT RIGHT HEEL COUNTER FOLDING CAUSING ULCER ON BACK OF HEEL CLINICIAN UNABLE TO SMOOTH MATERIAL CAUSING SWELLING.