BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKER

    MDR report key: 5077312 · Received September 15, 2015

    Report

    Report Number
    5077312
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Date of Event
    August 28, 2015
    Report Date
    September 2, 2015
    Manufacturer
    MEDICAL DEPOT D/B/A DRIVE MEDICAL DESIGN AND MANUFACTURING
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BARIATRIC ROLLING WALKER RATED FOR 500 LBS. WAS BEING USED WITH (B)(6) PATIENT IN THE GYM. THE BUTTON FOR ADJUSTING THE HEIGHT OF THE ROLLING WALKER BECAME DISASSEMBLED FROM THE SPRING. MANUFACTURER RESPONSE FOR BARIATRIC ROLLING WALKER, BARIATRIC ALUMINUM FOLDING WALKER, TWO BUTTON (PER SITE REPORTER): AS OF THIS REPORT, NO RESPONSE HAS BEEN GIVEN BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608325 WALKER ITJ MEDICAL DEPOT D/B/A DRIVE MEDICAL DESIGN AND MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR NO OTHER DEVICES USED