BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4861627 · Received June 18, 2015

    Report

    Report Number
    4861627
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    April 17, 2015
    Report Date
    May 28, 2015
    Manufacturer
    MEDICAL DEPOT D/B/A DRIVE MEDICAL DESIGN AND MANUFACTURING
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTED THAT SHE FELL DOWN IN HER HOME. ONE OF THE LEGS CLOSEST TO THE USER BROKE OFF.======================MANUFACTURER RESPONSE FOR WALKER, DELUX FOLDING WALKER, TWO BUTTON WITH 5" WHEELS (PER SITE REPORTER).======================THEY CALLED AND REQUIRED I SEND THE WALKER BACK TO THEM FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398320 * WALKER ITJ MEDICAL DEPOT D/B/A DRIVE MEDICAL DESIGN AND MANUFACTURING * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR