InjuryKNP
DR COMFORT
Received Dec 29, 2025 · Event occurred Dec 2, 2025
Report 3008579854-2025-00008 · MDR key 23917906
Device
Generic name
Winner Plus White 12 Xwide
Manufacturer
Dr Comfort; A Djo Llc CompanyCatalog number
7240R-X-12.0
Lot number
UNKNOWN
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Male
- Ulcer
- Ulcer
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED BY THE PATIENT THAT THE SHOE HAS CAUSED AN UPEN WOUND ON HIS TOE. THE SHOE HAS NOT BEEN RETURNED FOR EVALUATION, 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 BY THE PATIENT THAT THE SHOE HAS CAUSED AN UPEN WOUND ON HIS TOE.