BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERTURN ELITE MATTRESS

    MDR report key: 4024961 · Received August 13, 2014

    Report

    Report Number
    MW5037779
    Event Type
    Injury
    Date Received
    August 13, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 12, 2014
    Manufacturer
    BLUE CHIP MEDICAL PRODUCTS INC.
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RESIDENT WAS PLACED ON AIR MATTRESS 4 DAYS PRIOR TO INCIDENT AS PART OF A TREATMENT PLAN FOR PRESSURE ULCERS ON RESIDENT'S BACK. RESIDENT HAD BEEN ON THE MATTRESS FOR 4 DAYS WITHOUT INCIDENT. ON (B)(6) 2014 AT 5:10PM RESIDENT COULD BE HEARD YELLING OUT FOR HELP. WHEN STAFF ENTERED ROOM, RESIDENT WAS FOUND ON FLOOR WITH MATTRESS LAYING UPSIDE DOWN ON TOP OF HIM. RESIDENT WAS TAKEN TO EMERGENCY DEPT WHERE HE RECEIVED SUTURES TO A LACERATION TO HIS FOREHEAD AND SURGICAL ADHESIVE TO A LACERATION ON HIS CHIN. HE ALSO SUSTAINED ABRASIONS TO HIS KNEES AND A LARGE SKIN TEAR TO HIS RIGHT ELBOW. STRAPS THAT HELD THE POWERTURN ELITE MATTRESS TO THE BED FRAME SEPARATED FROM THE POWERTURN ELITE MATTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482913 POWERTURN ELITE MATTRESS POWERTURN ELITE MATTRESS FNM BLUE CHIP MEDICAL PRODUCTS INC. 9800

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization