DR COMFORT
Received Sep 14, 2024 · Event occurred Jun 6, 2024
Report 9616086-2024-00071 · MDR key 20219198
Device
Generic name
L5000 Toe Filler Custom Insole
Manufacturer
Djo LlcCatalog number
17-0004-0-00000
Lot number
13833627
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Neuropathy
- Ulcer
- Neuropathy
- Ulcer
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE CUSTOM INSOLE AND SHOE CAUSED PAIN; SHOE RUBBED AND CAUSED ULCER ON DORSAL 2ND TOE. TOE FILLER DOES NOT MATCH FOOT, AMPSITE IS HITTING THE FILLER, FILLER NOT WIDE ENOUGH PRODUCT WITH THE CUSTOMER REPORTED ISSUE WAS RETURNED AND INVESTIGATED BY A QUALITY TECHNICIAN AND DEFECT CONFIRMED, CUSTOM IS MISASSSMEBLED (NOT WIDE ENOUGH, NOT MATCHING PT CLONE). ROOT CAUSE IS TRACED TO THE MANUFACTURING PROCESS OF THE CUSTOM INSOLE.
Description of Event or Problem
IT WAS REPORTED THAT THE CUSTOM INSOLE AND SHOE CAUSED PAIN; SHOE RUBBED AND CAUSED ULCER ON DORSAL 2ND TOE. TOE FILLER DOES NOT MATCH FOOT, AMPSITE IS HITTING THE FILLER, FILLER NOT WIDE ENOUGH