BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENNER

    MDR report key: 2394898 · Received November 15, 2011

    Report

    Report Number
    1922538-2011-00002
    Event Type
    Injury
    Date Received
    November 15, 2011
    Date of Event
    November 1, 2011
    Report Date
    November 14, 2011
    Manufacturer
    PENNER MANUFACTURING, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESIDENT WAS NOT BELTED CORRECTLY (PER SAFETY AND DAILY MAINTENANCE INSTRUCTION MANUAL). IN-SERVICE TRAINING WAS AGAIN PROVIDED BY KIRK PENNER, PENNER MFG INC REP. THE FACILITY WAS AGAIN GIVEN A SECOND BELT FOR USE AROUND THE UPPER BODY TO PREVENT LEANING FORWARDED (PER SAFETY AND DAILY MAINTENANCE INSTRUCTION MANUAL).

    Description of Event or Problem · 1

    AFTER THE BATH WAS FINISHED, THE STAFF RAISED THE TRANSFER HALF WAY UP AND MOVED THE RESIDENT OUT OF THE SPA. ONCE OUT OF THE SPA, CONTINUED TO MOVE THE PT TO THE CORNER WITHOUT LOWERING THE TRANSFER TO ITS LOWEST POSITION FIRST (PER SAFETY AND DAILY MAINTENANCE INSTRUCTION MANUAL). THE RESIDENT LIKES TO REACH FOR OBJECTS IN FRONT OF HIM AND STARTED TO FALL FORWARD OUT OF THE CHAIR WHILE STILL BEING BELTED IN THE CHAIR. THE RESIDENT TWISTED SLIGHTLY AND FELL TO THE FLOOR ON THE RIGHT SIDE WITH THE BELT ENDING UP AROUND HIS FEET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENNER PATIENT TRANSFER FSA PENNER MANUFACTURING, INC. 383000-1

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization