DR COMFORT
Received Sep 29, 2025 · Event occurred Sep 2, 2025
Report 9616086-2025-00064 · MDR key 23176263
Device
Generic name
L5000 Toe Filler Custom Insole
Manufacturer
Djo LlcCatalog number
17-0004-0-00000
Lot number
UNKNOWN
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Abrasion
- Abrasion
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE INSERT WITH THE TOE FILLER WAS A BIT DIFFERENT THAN THE ONE HE HAD. THE PATIENT WAS COMPLAINING THAT HIS FOOT WAS BLEEDING FROM THE INSERT. NO MEDICAL TREATMENT WAS PROVIDED PATIENT TREATED HIMSELF AT HOME. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, THE EVALUATION OF THE PHOTO SHOWS THE TOE FILLER IS NOT MADE THE SAME AS THE LAST ONE. THE ROOT CAUSE COULD HAVE BEEN DUE A MANUFACTURING PROCESS PROBLEM.
Description of Event or Problem
IT WAS REPORTED THAT THE INSERT WITH THE TOE FILLER WAS A BIT DIFFERENT THAN THE ONE HE HAD. THE PATIENT WAS COMPLAINING THAT HIS FOOT WAS BLEEDING FROM THE INSERT. NO MEDICAL TREATMENT WAS PROVIDED PATIENT TREATED HIMSELF AT HOME.