DR COMFORT
Received Sep 12, 2025 · Event occurred Aug 18, 2025
Report 3008579854-2025-00002 · MDR key 23044768
Device
Generic name
Brian X Black 12 Med
Manufacturer
Dr Comfort; A Djo Llc CompanyCatalog number
6910-M-12.0
Lot number
UNKNOWN
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Ulcer
- Ulcer
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A PLASTIC TOE PUFF THAT RUBBED THE PATIENTS HAMMER TOE WHICH LED TO AN ULCER AND THEN AMPUTATION.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THERE WAS A PLASTIC TOE PUFF THAT RUBBED THE PATIENTS HAMMER TOE WHICH LED TO AN ULCER AND THEN AMPUTATION. THE SHOE WAS RETURNED AND EVALUATED. THE COMPLAINT HAS BEEN CONFIRMED; EVALUATION OF THE SHOE FOUND THE TOE BOX SUPPORT IS BENT DOWN AND CAN FEEL THE EDGE OF IT. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.