inforMED
InjuryKNP

DR COMFORT

Received Feb 4, 2026 · Event occurred Jan 8, 2026

Report 3008579854-2026-00002 · MDR key 24264693

Device

Generic name

Jason Red 9 1/2 Xwid

Catalog number

77770-X-09.5

Lot number

UNKNOWN

Product problems

  • Patient Device Interaction Problem

Patient

NA · Unknown

  • Ulcer

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE SHOE CAUSED WOUND MEDIAL RIGHT HALLUX. THE SHOE WAS NOT RETURNED AND EVALUATED. THE COMPLAINT HAS BEEN HAS NOT BEEN CONFIRMED; THE ROOT CAUSE COULD NOT BE ESTABLISHED. 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 SHOE CAUSED WOUND MEDIAL RIGHT HALLUX.