BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABLE LIFE SPACE SAVING WALKER

    MDR report key: 11731581 · Received April 26, 2021

    Report

    Report Number
    MW5100994
    Event Type
    Injury
    Date Received
    April 26, 2021
    Date of Event
    April 11, 2021
    Report Date
    April 22, 2021
    Manufacturer
    ABLE LIFE / STANDER INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    WALKER HANDLE BROKE CAUSING FALL THAT INJURED LEG. NEEDS WALKER TO ASSIST WALKING DUE TO RADIATION CAUSED DAMAGE TO SPINE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618434 ABLE LIFE SPACE SAVING WALKER WALKER, MECHANICAL ITJ ABLE LIFE / STANDER INC. 4200-B

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization