BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISOFLEX MEDSURG MATTRESS MODEL

    MDR report key: 2354888 · Received November 10, 2011

    Report

    Report Number
    1313850-2011-00417
    Event Type
    Other
    Date Received
    November 10, 2011
    Date of Event
    October 14, 2011
    Report Date
    October 14, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MATTRESS WAS DISCARDED BY CUSTOMER AS THEY DETERMINED THE CONTAMINATED SECTION COULD NOT BE REPLACED. A NEW MATTRESS WAS SENT TO THE CUSTOMER UNDER WARRANTY.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A SMALL AMOUNT OF BODILY FLUID INGRESSED INTO THE MATTRESS. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOFLEX MEDSURG MATTRESS MODEL MATTRESS IKY STRYKER CORP DBA GAYMAR 2800100997 NA

    Patients

    Seq Age Sex Outcome Treatment
    1