InjuryKYS
DR COMFORT
Received Jul 2, 2018 · Event occurred Jun 25, 2018
Report 3008579854-2018-00006 · MDR key 7654934
Device
Generic name
L5000 Tma Toe Filler Custom Insole
Manufacturer
Dr Comfort, A Djo, Llc CompanyModel number
12-3123-0-50000Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Ulcer
- Ulcer
Narrative
Description of Event or Problem
COMPLAINT RECEIVED THAT ALLEGES "GLUE HAS COME OFF THE TOP COVER THAT CAUSED SERIOUS INJURY. CREATED ULCER ON THE SOLE OF PTS FOOT LIKE A SILVER DOLLAR SIZE THAT MAY CAUSE AMPUTATION TO THE PT".