BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3000604 · Received March 12, 2013

    Report

    Report Number
    1525712-2013-01904
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 14, 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

    (B)(4). THE DEALER REPORTED THAT THE CROSSFIRE CT6A CUSTOM MECHANICAL WHEELCHAIR WHEEL LOCKS, TIRES AND THE CUSHION WERE WORN, AND THE BARS ALONGSIDE THE LEGS WERE NOT FITTING PROPERLY. THERE WAS NOT PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104172 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET CT6A

    Patients

    Seq Age Sex Outcome Treatment
    1 36 Other