BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDCARE

    MDR report key: 2211981 · Received August 8, 2011

    Report

    Report Number
    2135150-2011-00007
    Event Type
    Other
    Date Received
    August 8, 2011
    Date of Event
    May 8, 2010
    Report Date
    August 3, 2011
    Manufacturer
    MEDCARE PRODUCTS, INC.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDCARE PROVIDES A TWO YEAR HARDWARE WARRANTY ON OUR PRODUCTS. THE MACHINE IN QUESTION WAS OVER FOUR YEARS OLD.

    Description of Event or Problem · 1

    RESIDENT FELL DOWN DURING TRANSFER TO TOILET VIA MEDCARE STAND. TWO MAST/BASE BOLTS BROKE CAUSING THE MAST TO MOVE TOWARDS THE RESIDENT. THE RESIDENT FELL TO THE FLOOR WITH HER FEET STILL IN THE FOOT TRAY AND KNEE PAD PUSHING HER SHINS DOWNWARD. BRUISING WAS THE EXTENT OF THE RESIDENT'S INJURIES. BRUISING ON HER LEGS FROM THE KNEE PAD AND A BRUISED RIGHT ARM FROM HITTING THE WALL. NO HOSPITALIZATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDCARE STAND FNG MEDCARE PRODUCTS, INC. 4000002

    Patients

    Seq Age Sex Outcome Treatment
    1