InjuryKNP
DR COMFORT
Received Sep 17, 2025 · Event occurred Aug 25, 2025
Report 3008579854-2025-00004 · MDR key 23080671
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
- Abrasion
- Abrasion
Narrative
Description of Event or Problem
IT WAS REPORTED THAT RIGHT BIG TOE DEVELOPED A BLISTER AND BLEEDING DUE TO RUBBING.
Additional Manufacturer Narrative
IT WAS REPORTED THAT RIGHT BIG TOE DEVELOPED A BLISTER AND BLEEDING DUE TO RUBBING. THE SHOE WAS RETURNED BUT WAS NOT INVESTIGATED BY A QUALITY TECHNICIAN BECAUSE RETURNS DID NOT GIVE PRODUCT TO QUALITY FOR EVALUATION. THE ISSUE HAS NOT BEEN CONFIRMED AS REPORTED. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.