InjuryKYS

L5000 TOE FILLER CUSTOM INSOLE

Received Apr 24, 2024 · Event occurred Aug 10, 2023

Report 9616086-2024-00034 · MDR key 19177646

Device

Generic name

Insoles, Medical

Manufacturer

Djo Llc

Model number

17-0004-0-00000

Product problems

Device Misassembled During Manufacturing /Shipping
Device Misassembled During Manufacturing /Shipping

Patient

NA · Unknown

Ulcer
Ulcer

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT THERE WAS A HARD SPOT ON THE ORTHOTIC THAT CAUSED OPEN WOUND. THE PATIENT WAS TREATED FOR THE WOUND WITH DEBRIDEMENT AND ROUTINE DRESSING CHANGES. THE RETURNED PRODUCT INSPECTED AND COMPLAINT WAS CONFIRMED

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A HARD SPOT ON THE ORTHOTIC THAT CAUSED OPEN WOUND. THE PATIENT WAS TREATED FOR THE WOUND WITH DEBRIDEMENT AND ROUTINE DRESSING CHANGES.