inforMED
InjuryKNP

DR COMFORT

Received Sep 17, 2025 · Event occurred Aug 21, 2025

Report 3008579854-2025-00003 · MDR key 23080662

Device

Generic name

Jack, Grey, Men,08.5, Wide

Catalog number

51080-W-08.5

Lot number

KS-52-24

Product problems

  • Patient Device Interaction Problem
  • Patient Device Interaction Problem

Patient

NA · Male

  • Abrasion
  • Abrasion

Narrative

Description of Event or Problem

IT WAS REPORTED THAT SHOE RUBBED HIS ANKLE UNTIL IT BLED AND LEFT THE PATTERN OF THE SEAM ON HIS FOOT.

Additional Manufacturer Narrative

IT WAS REPORTED THAT SHOE RUBBED HIS ANKLE UNTIL IT BLED AND LEFT THE PATTERN OF THE SEAM ON HIS FOOT. THE SHOE WAS RETURNED AND EVALUATED. THE COMPLAINT HAS BEEN CONFIRMED; EVALUATION OF THE SHOE FOUND THERE IS A SEAM INSIDE THE HEEL COUNTER. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.