BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 7520665 · Received May 16, 2018

    Report

    Report Number
    2438477-2018-00027
    Event Type
    Injury
    Date Received
    May 16, 2018
    Date of Event
    April 24, 2018
    Report Date
    May 16, 2018
    Manufacturer
    SHENYANG HENYI ENTERPRISE CO., LTD
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Description of Event or Problem · 1

    (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A PATIENT LIFT. THE DEVICE WAS DELIVERED AND NOT ASSEMBLED CORRECTLY. THE CAREGIVER REPORTED THAT THE DEVICE WAS NOT DEFECTIVE, HOWEVER, THE DELIVERY GUY ASSEMBLED THE PATIENT LIFT INCORRECTLY. IN HIS HASTE HE DID NOT SCREW THE THUMBSCREW ALL THE WAY IN. THE PATIENT'S LEG CAUGHT WAS SUFFERED A 6 INCH SKIN TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360431 DRIVE PATIENT LIFT FSA SHENYANG HENYI ENTERPRISE CO., LTD 13023SV

    Patients

    Seq Age Sex Outcome Treatment
    1 Other