BEUDAMED
    FDA Adverse Event Summary report: N

    STRYKER IMPRESSION

    MDR report key: 2426076 · Received January 10, 2012

    Report

    Report Number
    MW5023910
    Date Received
    January 10, 2012
    Report Date
    January 10, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    IKY
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    URGENT ADVISORY (B)(4) WAS SENT TO FACILITIES DEPARTMENT AT (B)(6) ON (B)(6) 2011. UPON RECEIPT THE FACILITIES SUPERVISOR CHECKED TO SEE IF WE HAD THE MATTRESSES IN QUESTION WHICH WE DID 106 OF THEM, PER THE ADVISORY, STRYKER HAD DETERMINED THAT SOME OF THESE SUPPORT SURFACES MAY SHOW AN INCREASE OF FOAM COMPRESSION. ON (B)(6) 2011, A REQUEST WAS SENT TO STRYKER TO DETERMINE THE REPLACEMENT PROCESS FOR DEFECTIVE MATTRESSES AS WE WERE CONCERNED ABOUT SKIN ISSUES AND PRESSURE ULCERS AS A RESULT OF THE BREAKDOWN IN THE SUPPORT SURFACE. WORK ORDERS BEGAN COMING IN THE ENGINEERING ON 12/20 REGARDING MATTRESS BREAKDOWN AND PT COMPLAINTS. UPON INSPECTION, SO FAR THE MATTRESSES ARE FAILING IN THE AREA THAT A PT'S WEIGHT WOULD REST DURING SITTING POSITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1