inforMED
InjuryKNP

DR COMFORT

Received Mar 30, 2026 · Event occurred Mar 2, 2026

Report 3008579854-2026-00003 · MDR key 24722024

Device

Generic name

Justin Chestnut 11 1/2 Xwide

Catalog number

5520-X-11.5

Lot number

HY-42-23

Product problems

  • Patient Device Interaction Problem

Patient

NA · Unknown

  • Ulcer

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE HEEL OF THE SHOW FOLDED AND PATIENT DEVELOPED AN OPEN WOUND ON HEEL, THE INJURY REQUIRED MEDICAL TREATMENT EVALUATION OF SHOE FOUND THE PLASTIC HEEL COUNTER WAS BENT IN. CAN FEEL IT THROUGH THE FABRIC, COMPLAINT HAS BEEN CONFIRMED THE ROOT CAUSED MAY HAVE BEEN ATTRIBUTED TO THE MANUFACTURING PROCESS. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.

Description of Event or Problem

IT WAS REPORTED THAT THE HEEL OF THE SHOW FOLDED AND PATIENT DEVELOPED AN OPEN WOUNDS ON HEEL, THE INJURY REQUIRED MEDICAL TREATMENT.