BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 2088453 · Received April 22, 2011

    Report

    Report Number
    2438477-2011-00005
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    August 27, 2010
    Report Date
    March 24, 2011
    Manufacturer
    APEX HEALTH CARE MFG., INC.
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DRIVE MEDICAL HAS RECEIVED A CUSTOMER COMPLAINT AND AN ATTORNEY LETTER ON A PATIENT LIFT ALLEGEDLY DISTRIBUTED BY OUR COMPANY. THE PATIENT WAS BEING TRANSFERRED OUT OF BED BUT THE AID HAD FAILED TO LOCK THE LEGS ON THE LIFT. AS A RESULT, THE LIFT ALLEGEDLY COLLAPSED AND THE PATIENT FELL BACK DOWN TO THE BED. IT WAS ALLEGED THAT THE FALL FROM THE LIFT CAUSED THE PLATES IN THE PATIENT'S HEAD FROM PREVIOUS SURGERY TO SHIFT OUT OF PLACE, AND CONSEQUENTLY CORRECTIVE SURGERY WAS PERFORMED. THIS MDR REPORT IS BASED ON THE CUSTOMER COMPLAINT AND ATTORNEY LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL PATIENT LIFT FNG APEX HEALTH CARE MFG., INC. 13240 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention