BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 1980191 · Received February 4, 2011

    Report

    Report Number
    MW5019257
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 25, 2011
    Report Date
    February 4, 2011
    Manufacturer
    DRIVE MEDICAL DEPOT, INC.
    Product Code
    INN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAD RECONSTRUCTIVE SURGERY DUE TO A FRACTURED TIBIAL PLATEAU. WAS TOLD BY PHYSICIAN TO BE NON WEIGHT BEARING FOR 30-45 DAYS. HE HAD TO UTILIZE TUB BENCH WHILE SHOWERING. ON (B)(6) 2011, ONE LEG OF THE BENCH COLLAPSED; NO INJURY NOTED. REPLACEMENT DEVICE WAS RECEIVED (B)(6) 2011. ON (B)(6) 2011, BOTH REAR LEGS OF DEVICE COLLAPSED. PT FELL BACKWARD AND HIT HIS BACK. HE WILL BE TAKING X-RAYS ON (B)(6) 2011. PT SUGGESTS THAT THERE IS A DEFECT WITH THE PEGS THAT ALLOW SOAP AND WATER TO GET BEHIND THEM AND CAUSES SLIPPAGE OF DEVICE AND EVENTUAL COLLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL TUB/ BENCH INN DRIVE MEDICAL DEPOT, INC. 12446-2

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR