inforMED
InjuryKYS

DR COMFORT

Received Jun 25, 2018 · Event occurred May 18, 2018

Report 3008579854-2018-00005 · MDR key 7634246

Device

Generic name

A5513 Pour Accomm Custom Insoles

Model number

17-0003-0-00000

Product problems

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

Patient

Not reported

  • Patient Problem/Medical Problem
  • Patient Problem/Medical Problem

Narrative

Description of Event or Problem

COMPLAINT RECEIVED THAT ALLEGES "PATIENT HAS A WOUND THAT REOPENED AFTER SHE STARTED WEARING OUR INSERTS AND SHE IS BEING SEEN FOR HYPERBARIC TREATMENTS".