BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3250495 · Received July 26, 2013

    Report

    Report Number
    1525712-2013-06206
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Report Date
    July 10, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES THE END-USER ALLEGES A SCREW BROKE IN HALF CAUSING A PIECE THAT ATTACHES THE FOOTREST FRAME TO COME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351038 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET SOLARA2G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other