DR COMFORT
Received May 6, 2026 · Event occurred Apr 10, 2026
Report 9616086-2026-00018 · MDR key 25107491
Device
Generic name
L5000 Toe Filler Custom Insole
Manufacturer
Djo LlcCatalog number
17-0004-0-00000
Lot number
15077760
Product problems
- Patient Device Interaction Problem
Patient
NA · Unknown
- Tissue Breakdown
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE CARBON PLATE IS NOT WITH THE SHOE AND THE FILLER MODIFICATIONS ARE TOO AGGRESSIVE EVEN WITH MODIFYING THE FILLER. NEEDS LESS AGGRESSIVE PUSH AGAINST THE FOOT CAUSING THE SORE TO REOPEN.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE CARBON PLATE IS NOT WITH THE SHOE AND THE FILLER MODIFICATIONS ARE TOO AGGRESSIVE EVEN WITH MODIFYING THE FILLER. NEEDS LESS AGGRESSIVE PUSH AGAINST THE FOOT CAUSING THE SORE TO REOPEN. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, COMPLAINT COULD NOT BE CONFIRMED, THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.