inforMED
InjuryKYS

DR COMFORT

Received Mar 9, 2018 · Event occurred Jun 6, 2017

Report 3008579854-2018-00002 · MDR key 7327365

Device

Generic name

L5000 Toe Filler Custom Insole

Manufacturer

Djo, Llc

Model number

17-0004-0-00000

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Pressure Sore/Ulcer
  • Pressure Sore/Ulcer

Narrative

Description of Event or Problem

COMPLAINT RECEIVED THAT ALLEGES "PATIENT DEVELOPED ULCERS, PT DEVELOPING RECURRENT ULCERATION, PATIENT DEVELOPED HUGE ULCERS FROM WEARING THE TOE FILLER".