DR COMFORT
Received Aug 5, 2025 · Event occurred Feb 17, 2025
Report 9616086-2025-00055 · MDR key 22722969
Device
Generic name
A5514 Regular Accomm Custom Insoles
Manufacturer
Djo LlcCatalog number
17-0001-0-00000
Lot number
14370928
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 CLAIMS HEEL IS TOO HIGH CAUSING WEIGHT FORWARD AND PRESURE ON BALL OF FOOT CAUSING BLISTERS AND OPEN WOUND THAT REQUIRED MEDICAL TREATMENT. THE CUSTOM INSOLE WAS RETURNED FOR EVALUATION; CUSTOM INSERTS FOUND NO DEFECT. CUSTOMS WERE MADE TO SPECIFICATION. THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT IF MORE INFORMARTION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT CLAIMS HEEL IS TOO HIGH CAUSING WEIGHT FORWARD AND PRESURE ON BALL OF FOOTM CAUSING BLISTERS AND OPEN WOUND THAT REQUIRED MEDICAL TREATMENT.