BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3013788 · Received March 20, 2013

    Report

    Report Number
    1525712-2013-02119
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER (B)(6), ON THE UPPER ARM TUBE THAT ARM PAD ATTACHES TO THE WELD BROKE WHERE THE VERTICAL REAR PART OF UPPER ARM TUBE CONNECTS TO THE HORIZONTAL TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116241 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET PROX4S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other