DR COMFORT
Received Oct 10, 2024 · Event occurred Dec 11, 2023
Report 3008579854-2024-00007 · MDR key 20424165
Device
Generic name
Winner X Black 8 Xwide
Manufacturer
Dr Comfort; A Djo, Llc CompanyCatalog number
7710-X-08.0
Lot number
FY-01-23; 13400367
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Fall
- Limb Pain
- Fall
- Limb Pain
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE SHOE CAUSED PAIN, NOT HOLDING, FOOT ROTATES TO THE OUTSIDE AND PATIENT FALLS FREQUENTLY. THE PRODUCT WAS NOT RETURNED FOR EVALUATION, THE ISSUE CANNOT BE CONFIRMED AS REPORTED. THE ROOT CAUSE COULD NOT BE ESTABLISHED. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT.
Description of Event or Problem
IT WAS REPORTED THAT THE SHOE CAUSED PAIN, NOT HOLDING, FOOT ROTATES TO THE OUTSIDE AND PATIENT FALLS FREQUENTLY.