DR COMFORT
Received Jan 29, 2025 · Event occurred Jan 2, 2025
Report 9616086-2025-00009 · MDR key 21270252
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 THE PATIENT DEVELOPED A WOUND ON THE DORSAL 2ND DIGIT IPJ. PATIENT WAS TREATED BY A DOCTOR IN THE DOCTOR'S OFFICE, NO HOSPITALIZATION OR AMPUTATION. BOTH FEET ARE FORMING CALLUSES ON DORSAL IPJ ON DIGITS 2-4. PATIENT WAS WEARING OR A FEW WEEKS. WOUND INTO LIMITED TO THE BREAKDOWN OF SKIN. THE CUSTOM INSOLE WAS RETURNED AND INVESTIGATED BY A QUALITY TECHNICIAN. THE ISSUE HAS NOT BEEN CONFIRMED AS REPORTED. THE ROOT CAUSE COULD NOT BE ESTABLISHED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED A WOUND ON THE DORSAL 2ND DIGIT IPJ. PATIENT WAS TREATED BY A DOCTOR IN THE DOCTORS OFFICE, NO HOSPITALIZATION OR AMPUTATION. BOTH FEET ARE FORMING CALLUSES ON DORSAL IPJ ON DIGITS 2-4. PATIENT WAS WEARING OR A FEW WEEKS. WOUND INTO LIMITED TO THE BREAKDOWN OF SKIN.