InjuryKYS
DR COMFORT
Received Jul 25, 2025 · Event occurred Jul 1, 2025
Report 9616086-2025-00054 · MDR key 22620381
Device
Generic name
L5000 Toe Filler Custom Insole
Manufacturer
Djo LlcCatalog number
17-0004-0-00000
Lot number
14238693
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Female
- Tissue Breakdown
- Tissue Breakdown
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PAIR OF CUSTOM INSERTS FROM (B)(6) 2024 CAUSED A WOUND THAT EQUIRED MEDICAL TREATMENT. THE CUSTOM INSOLE WAS NOT RETURNED FOR EVALUATION, 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 PAIR OF CUSTOM INSERTS FROM (B)(6) 2024 CAUSED A WOUND THAT EQUIRED MEDICAL TREATMENT.