InjuryKYS
DR COMFORT
Received Mar 20, 2025 · Event occurred Dec 10, 2024
Report 9616086-2025-00033 · MDR key 21659795
Device
Generic name
L5000 Toe Filler Custom Insole
Manufacturer
Djo LlcCatalog number
17-0004-0-00000
Lot number
2410099
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 4TH TOE THAT REQUIRED WOUND CARE FOR SEVERAL WEEKS. 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 INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED A WOUND ON 4TH TOE THAT REQUIRED WOUND CARE FOR SEVERAL WEEKS.