inforMED
InjuryKYS

DR COMFORT

Received Jul 9, 2018 · Event occurred Jun 20, 2018

Report 3008579854-2018-00007 · MDR key 7670309

Device

Generic name

K0903 Special Accomm Custom Insoles

Model number

17-0002-0-00000

Product problems

  • Appropriate Device Problem Term/Code Not Available
  • Appropriate Device Problem Term/Code Not Available

Patient

Not reported

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

Narrative

Description of Event or Problem

COMPLAINT RECEIVED THAT ALLEGES "PATIENT EXPERIENCED STAPH INFECTION BECAUSE THE INSERT IS AN INCH SMALLER THAN THE SHOES"