DR COMFORT
Received Sep 20, 2024 · Event occurred Jun 2, 2024
Report 9616086-2024-00079 · MDR key 20274362
Device
Generic name
L5000 Toe Filler Custom Insole
Manufacturer
Djo LlcCatalog number
17-0004-0-00000
Lot number
2351211
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Tissue Breakdown
- Tissue Breakdown
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE SHOE FELT TOO TIGHT ON TOP BY THE LACES/TOE FILLER. CAUSING TRAUMA TO AMP SITE, WAS BLEEDING, PATIENT FEELS LIKE AREA IS TOO NARROW ON RIGHT MET. THE CUSTOM INSOLE WAS RETURNED AND EVALUATED DEFECT CONFIRMED. ITEM IS MISASSEMBLED AND DOES NOT MATCH PATIENTS FOOT. THE ROOT CAUSE HAS BEEN TRACED BACK TO A MANUFACTURING OF THE CUSTOM INSOLE.
Description of Event or Problem
IT WAS REPORTED THAT THE SHOE FELT TOO TIGHT ON TOP BY THE LACES/TOE FILLER. CAUSING TRAUMA TO AMP SITE, WAS BLEEDING, PATIENT FEELS LIKE AREA IS TOO NARROW ON RIGHT MET.