BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 8829221 · Received July 25, 2019

    Report

    Report Number
    2438477-2019-00046
    Event Type
    Injury
    Date Received
    July 25, 2019
    Date of Event
    June 15, 2019
    Report Date
    July 25, 2019
    Manufacturer
    SHENYANG HENYI ENTERPRISE CO., LTD
    Product Code
    FSA
    UDI-DI
    00822383291581
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A TRAPEZE. FACILITY STATES THAT IT WASN'T IN THE ROOM WHEN THE TRAPEZE BROKE. IT IS BELIEVED THAT THE RESIDENT WAS PULLING ON THE TRAPEZE AND USING IT IN WAYS NOT INTENDED FOR THE PRODUCT. THE RESIDENT SUBTAINED A BROKEN TAILBONE AND WAS TRANSPORTED TO THE HOSPITAL. THE FREE STANDING TRAPEZE IS AT THE FACILITY'S WAREHOUSE. THE TRIANGLE IS IN THE RESIDENT'S POSSESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620441 DRIVE PATIENT LIFT FSA SHENYANG HENYI ENTERPRISE CO., LTD 13041SV 00822383291581

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization