DR COMFORT
Received Nov 20, 2025 · Event occurred Oct 22, 2025
Report 3008579854-2025-00006 · MDR key 23601607
Device
Generic name
Performance Black 12.0 Wd
Manufacturer
Dr Comfort; A Djo Llc CompanyCatalog number
7611R-W-12.0
Lot number
UNKNOWN
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Ulcer
- Ulcer
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THAT PIECE ON THE RIGHT HEEL HAS SOME SORT OF DEFECT THAT WORE THROUGH THE PADDING CAUSING AN ULCER ON HIS HEEL. THIS REQUIRED A TRIP TO THE ER. HE HAD TO HAVE INTRAVENOUS ANTIBIOTICS ADMINISTERED AN ORAL ANTIBIOTICS FOR 2 WEEKS. THE SHOE HAS NOT BEEN RETURNED FOR EVALUATION, COMPLAINT COULD NOT BE CONFIRMED, 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 THAT PIECE ON THE RIGHT HEEL HAS SOME SORT OF DEFECT THAT WORE THROUGH THE PADDING CAUSING AN ULCER ON HIS HEEL. THIS REQUIRED A TRIP TO THE ER. HE HAD TO HAVE INTRAVENOUS ANTIBIOTICS ADMINISTERED AN ORAL ANTIBIOTICS FOR 2 WEEKS.