BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3150997 · Received June 6, 2013

    Report

    Report Number
    1525712-2013-04451
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 10, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER STATES CROSSBRACE BROKE AT TOP LEFT HAND SIDE OF CHAIR WHERE THE MOUNT HARDWARE ATTACHES TO THE CROSSBRACE. IT CRACKED AT THE SCREW HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251467 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET PROX4S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other