BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2993289 · Received March 7, 2013

    Report

    Report Number
    1525712-2013-01684
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED BY THE CONSUMER THAT THE SOLARA3G CUSTOM MECHANICAL WHEELCHAIR HAD BROKEN / MISSING ARMS. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97217 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other