BEUDAMED
    FDA Adverse Event Other Summary report: N

    BED, HOSPITAL

    MDR report key: 1221818 · Received November 3, 2008

    Report

    Report Number
    2182305-2008-00037
    Event Type
    Other
    Date Received
    November 3, 2008
    Date of Event
    August 19, 2008
    Report Date
    September 5, 2008
    Manufacturer
    JOERNS HEALTHCARE, INC.
    Product Code
    FNJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER, BY FACILITY, PER FACILITY, THEY WERE DOING A RESIDENT TRANSFER FROM HER BED, WHEN RESIDENT'S FOOT WAS CUT OPEN FROM THE SEAT PAN ON THE BED FRAME. PER FACILITY, THE PLASTIC SEAT PAN SUPPORT FOR THE BED IS VERY SHARP WITH JAGGED EDGES. THEY HAVE APPLIED MASKING TAPE OVER THE ROUGH EDGE OF THE RESIDENT'S BED TO COVER IT UP, SO SHE WOULD NOT GET CUT AGAIN. RESIDENT WAS SENT TO THE ER, WHERE SHE NEEDED 17 STITCHES TO CLOSE THE CUT. RMA ISSUED TO GET ENTIRE BED BACK FOR EVALUATION. REPLACEMENT ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED, HOSPITAL BED, HOSPITAL, ELECTRIC FNJ JOERNS HEALTHCARE, INC. U770 ULTRA CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other