DR COMFORT
Received May 6, 2026 · Event occurred Apr 9, 2026
Report 3008579854-2026-00004 · MDR key 25107493
Device
Generic name
Don, Black, 13.0, Medium
Manufacturer
Dr Comfort; A Djo Llc CompanyCatalog number
51910-M-13.0
Product problems
- Patient Device Interaction Problem
Patient
NA · Unknown
- Ulcer
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT ON THE LEFT SHOE THE TOP RIGID COUNTER END PLASTIC PIECE IS PROTRUDING AND IT CAUSED AND ULCER ON THE PATIENTS HEEL. PATIENT SAW THE PODIATRIST REGARDING THIS INJURY. THE SHOE HAS NOT BEEN RETURNED FOR EVALUATION, THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE ESTABLISHED. 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 ON THE LEFT SHOE THE TOP RIGID COUNTER END PLASTIC PIECE IS PROTRUDING AND IT CAUSED AND ULCER ON THE PATIENTS HEEL. PATIENT SAW THE PODIATRIST REGARDING THIS INJURY.