inforMED
InjuryKYS

DR COMFORT

Received Feb 23, 2018 · Event occurred Aug 1, 2017

Report 3008579854-2018-00001 · MDR key 7292457

Device

Generic name

A5513 Regular Accomm Custom Insoles

Manufacturer

Djo, Llc

Model number

17-0001-0-00000

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 HAD TO BE ADMITTED TO A WOUND CARE DUE TO ULCER. ULCER DEVELOPED ON DORSAL ASPECT OF THE TOES. THERE WAS NO PAIN". QUESTIONNAIRE NOT RECEIVED FROM CUSTOMER OR CLINICIAN. DEVICE NOT RECEIVED MANUFACTURER AT THIS TIME.