BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3080424 · Received April 26, 2013

    Report

    Report Number
    1525712-2013-03283
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) -THE DEALER REPORTED THAT THE PATIENT OF A TDXSP-CG POWER WHEELCHAIR WAS USING A TRANSPORTATION MOBILITY COMPANY, AND WAS BEING LIFTED INTO THE VEHICLE WITHOUT THE WHEEL LOCKS BEING ENGAGED, WHEN THE DRIVER PUSHED THE PATIENT FORWARD INTO THE BUS. SHE RAN INTO A METAL BENCH, RESULTING IN A SKIN CUT WITH NONSTOP BLEEDING. EMERGENCY MEDICAL ATTENTION WAS SOUGH, AND SHE RECEIVED STITCHES, AND WAS COMPLAINING OF NECK PAIN. SHOULD WE RECEIVE ADDITIONAL INFORMATION, THIS FILE WILL BE REVIEWED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NO PRODUCT MALFUNCTION WAS ALLEGED. ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THIS EVENT, ALTHOUGH TWO DIFFERENT COMPLAINTS WERE CREATED BECAUSE OF DIFFERENT PARTS NEEDED TO REPAIR THE UNIT, AND THE FILE NUMBERS ARE THE FOLLOWING: (B)(6) (MDR AND 1 OF 2), AND (B)(6) (2 OF 2).

    Description of Event or Problem · 1

    (B)(6) THE DEALER REPORTED THAT THE PATIENT OF A TDXSP-CG POWER WHEELCHAIR WAS USING A TRANSPORTATION MOBILITY COMPANY, AND WAS BEING LIFTED INTO THE VEHICLE WITHOUT THE WHEEL LOCKS BEING ENGAGED, WHEN THE DRIVER PUSHED THE PATIENT FORWARD INTO THE BUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182679 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET XTRA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 Other