inforMED
MalfunctionIPR

DRIVE

Received Jul 19, 2022 · Event occurred Jan 9, 2021

Report 2438477-2022-00050 · MDR key 15058044

Device

Generic name

Crutches

Model number

10402-1

Product problems

  • Break
  • Break

Patient

Male

  • Discomfort
  • Discomfort

Narrative

Description of Event or Problem

(B)(6) HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A CRUTCH REPORTED TO BE "DEFECTIVE," AND "APPEARS TO HAVE SNAPPED." THE END USER REPORTED EXACERBATION OF A BROKEN FOOT. DRIVE ATTEMPTED BUT WAS NOT ABLE TO RETRIEVE THE PRODUCTS FOR EVALUATION.