DR COMFORT
Received Feb 7, 2025 · Event occurred Nov 15, 2024
Report 9616086-2025-00007 · MDR key 21339782
Device
Generic name
A5514 Regular Accomm Custom Insoles
Manufacturer
Djo LlcCatalog number
17-0001-0-00000
Lot number
UNKNOWN
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 OFFLOAD AND METPAD MISPLACED. PATIENT DEVELOPED WOUND ON THE BOTTOM OF THEIR FOOT AS WELL AS TOES. PATIENT HAD TO ANTIBIOTICS FOR INJURY AND SEE THE DOCTOR MULTIPLE TIMES IN REGARDS TO THE INJURY. THE INSOLES WERE NOT RETURNED FOR EVALUATION. THE ROOT CAUSE COULD NOT BE ESTABLISHED. IF "ADDDITIONAL" REPORTING ON THIS EVENT IS PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT WILL BE PROVIDED.
Description of Event or Problem
IT WAS REPORTED THAT OFFLOAD AND METPAD MISPLACED. PATIENT DEVELOPED WOUND ON THE BOTTOM OF THEIR FOOT AS WELL AS TOES. PATIENT HAD TO ANTIBIOTICS FOR INJURY AND SEE THE DOCTOR MULTIPLE TIMES IN REGARDS TO THE INJURY.