BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRIVE MEDICAL

    MDR report key: 5088727 · Received September 18, 2015

    Report

    Report Number
    2438477-2015-00021
    Event Type
    Death
    Date Received
    September 18, 2015
    Report Date
    August 19, 2015
    Manufacturer
    SHENYANG HENYI ENTERPRISE CO., LTD.
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WV, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Description of Event or Problem · 1

    (B)(4) RECEIVED NOTICE FROM THE PROVIDER REGARDING AN INCIDENT INVOLVING A PATIENT LIFT, A DEVICE IMPORTED AND DISTRIBUTED BY (B)(4). A BOLT ALLEGEDLY BROKE FROM THE WHEEL OF THE PATIENT LIFT, CAUSING THE PATIENT TO FALL. PATIENT HIT HIS HEAD AND WAS HOSPITALIZED AT VARIOUS TIMES AFTER HIS FALL. HE LATER PASSED AWAY. THIS REPORT IS BASED ON INFORMATION RELAYED BY THE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618274 DRIVE MEDICAL PATIENT LIFT FSA SHENYANG HENYI ENTERPRISE CO., LTD. 13023SV

    Patients

    Seq Age Sex Outcome Treatment
    1 Death