BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2950981 · Received February 8, 2013

    Report

    Report Number
    1525712-2013-00966
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    February 8, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES PATIENT FELL OUT OF CHAIR AND TAKEN TO EMERGENCY ROOM TODAY PER DEALER. EXTENT OF INJURY NOT KNOWN BY DEALER. (B)(6) 2013 UPDATE: (B)(6) 10:43AM PROVIDER STATED (B)(6) FELL OUT OF CHAIR AFTER IT TURNED 90 DEGREES AND TAKEN TO EMERGENCY ROOM. PARTIALLY DUE TO LATCHES FOR HUB ASSEMBLIES NOT WORKING WELL ON CHAIR AND ON BACKORDER WITH INVACARE TILL (B)(6) 2013 PER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54544 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET SOLARA2G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other