BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER MEDICAL 1.5 IMPRESSION SUPPORT SURFACE

    MDR report key: 2430065 · Received January 20, 2012

    Report

    Report Number
    MW5023960
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 20, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED WITH HOSPITAL ACQUIRED PRESSURE ULCER AS THE RESULT OF DEFECTIVE SUPPORT SURFACE (MATTRESS). MATTRESS BROKE DOWN UNDER COCCYX AREA OF PT SO THAT WEIGHT OF PT WAS RESTING ON MATTRESS COVER AND METAL WITH NO SUPPORT BETWEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER MEDICAL 1.5 IMPRESSION SUPPORT SURFACE IMPRESSION 1.5 MATTRESS IKY STRYKER MEDICAL 2981

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR