BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2932051 · Received January 28, 2013

    Report

    Report Number
    1525712-2013-00669
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 28, 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

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES BOLTS THAT GO THROUGH THE CLAMPS, WHICH ATTACH THE WHEEL LOCKS ONTO THE CHAIR, KEPT LOOSENING UP. THE WHEEL LOCKS KEEP FALLING DOWN. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36868 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET PROX4S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other