inforMED
InjuryKYS

L5000 TOE FILLER CUSTOM INSOLE

Received Aug 22, 2017 · Event occurred Aug 1, 2017

Report 3008579854-2017-00005 · MDR key 6811820

Device

Generic name

L5000 Toe Filler Custom Insole

Manufacturer

Djo, Llc

Catalog 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

  • Wound Infection
  • Wound Infection

Narrative

Description of Event or Problem

COMPLAINT RECEIVED THAT ALLEGES "TOE FILLER CAME APART, PT HAS BEEN TO WOUND CARE. DEVICE CAUSED A BLISTER AT THE END OF THE STUMP AMPUTATION". QUESTIONNAIRE NOT RECEIVED FROM CUSTOMER OR CLINICIAN. DEVICE WAS RECEIVED BY MANUFACTURER AT THIS TIME.