BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX MEDSURG MATTRESS MODEL

    MDR report key: 2873542 · Received November 14, 2012

    Report

    Report Number
    1313850-2012-00334
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 16, 2012
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLUID IS LEAKING THROUGH THEIR ISOFLEX MATTRESS AND THE INSIDE IS DEVELOPING MOLD AND MILDEW. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1