BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2955099 · Received February 11, 2013

    Report

    Report Number
    1525712-2013-00987
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 10, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) THE DEALER REPORTED THAT THE 9XDT HEAVY DUTY MECHANICAL WHEELCHAIR CROSSBRACE LINK WAS BROKEN, AND THE USER SUSTAINED A MINOR CUT ON THE ALLEGEDLY EXPOSED SHARP EDGE, FROM THE INDEX FINGER TOWARDS THE HAND. NO MEDICAL ATTENTION WAS SOUGHT, AND SHOULD WE RECEIVE IT, THIS FILE WILL BE REVIEWED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59369 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET 9XDTHD

    Patients

    Seq Age Sex Outcome Treatment
    1 55 Other