BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2942805 · Received February 4, 2013

    Report

    Report Number
    1525712-2013-00820
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE DEALER REPORTED THAT THE HTR5000 TILT AND RECLINE MECHANICAL WHEELCHAIR SEAT BRACKETS WERE CRACKED AND BROKEN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46312 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET HTR5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other