DR COMFORT
Received Nov 20, 2025 · Event occurred Oct 22, 2025
Report 3008579854-2025-00007 · MDR key 23601606
Device
Generic name
Winner X Black 12 Wide
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
- Abrasion
- Abrasion
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT GLUE ON THE RIDGE OF THE SHOES IN THE RIGHT TOEBOX AREA IS SHARP AND CAUSED A HALLUX BLISTER. THE SHOE WAS RETURNED AND EVALUATED. EVALUATION OF SHOE FOUND HARD MATERIAL STICKING OUT FROM THE TOE BOX AREA, COMPLAINT HAS BEEN CONFIRMED. 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 GLUE ON THE RIDGE OF THE SHOES IN THE RIGHT TOEBOX AREA IS SHARP AND CAUSED A HALLUX BLISTER.