BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFTEM MARK IV

    MDR report key: 911026 · Received September 7, 2007

    Report

    Report Number
    1058908-2007-00003
    Event Type
    Other
    Date Received
    September 7, 2007
    Date of Event
    August 20, 2007
    Report Date
    September 5, 2007
    Manufacturer
    MILLENNIUM MEDICAL PRODUCTS, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON SEPTEMBER 5, 2007, HILL-ROM, INC. (DISTRIBUTOR OF MEDICAL DEVICE) INFORMED MILLENNIUM MEDICAL PRODUCTS, INC. (MANUFACTURER OF MEDICAL DEVICE) OF THE FOLLOWING INCIDENT. ON OR ABOUT 2007, HILL-ROM, INC. WAS NOTIFIED BY REP. A PATIENT WAS INJURED ON HER FACE DURING A LIFT AND TRANSFER BECAUSE THE UNIT'S LEGS WERE NOT FULLY OPEN AND SPREAD, AS REQUIRED. THE PATIENT WAS IMMEDIATELY SEEN BY A PHYSICIAN AND GIVEN PAIN MEDICATION AND ICE PACKS TO RELIEVE SWELLING. HILL-ROM, INC. REPEATED ITS IN-SERVICE STAFF TRAINING TO REITERATE THE IMPORTANCE OF PROPER OPERATION OF THE UNIT, ESPECIALLY FULLY OPENING AND SPREADING THE LEGS PRIOR TO OPERATION. CAUSE OF INCIDENT IS USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFTEM MARK IV PATIENT LIFT AND TRANSFER DEVICE FSA MILLENNIUM MEDICAL PRODUCTS, INC. LFT700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other