MalfunctionIPG
BREG POST-OP SHOE
Received Feb 25, 2013
Report 2028253-2013-00004 · MDR key 2975722
Device
Product problems
- Component Falling
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A DISTRIBUTOR REPORTED THAT A BREG POST-OP SHOE (#11194) SOLE FELL OFF THE SHOE AFTER BEING USED FOR LESS THAN 30 DAYS. THERE WAS NO INJURY REPORTED AND NO INFORMATION REGARDING THE PATIENT/USER. THE DEVICE WAS RETURNED TO BREG FOR EVALUATION.