BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI 500

    MDR report key: 1913749 · Received November 24, 2010

    Report

    Report Number
    9681684-2010-00053
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY CANNOT CONFIRM THE MODEL OF THE SLING USED DURING THE TRANSFER. FURTHER INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    DURING A TRANSFER FROM WHEELCHAIR TO BED, THE PT HAD A SEIZURE AND BEGAN CONVULSING. CONSEQUENTLY, THE PT DREW HER LEGS TO HER CHEST AND HER BUTTOCKS SLID THROUGH THE OPENING BETWEEN THE LEG STRAPS ON SLING. THE PT HIT HER HEAD ON EITHER THE FLOOR OR THE LIFT DEVICE LEGS AND SUSTAINED A SMALL LACERATION THAT REQUIRED TWO STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI 500 LIFT, PATIENT, NON AC POWERED FSA BHM MEDICAL, INC. KM560081

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention