BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX 35X84X6 NYLON

    MDR report key: 3955708 · Received August 31, 2012

    Report

    Report Number
    1313850-2012-00258
    Event Type
    Malfunction
    Date Received
    August 31, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 6, 2012
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    HOW WAS THE ISSUE NOTICED; WAS THIS IDENTIFIED DURING, PRIOR, OR AFTER MEDICAL PROCEDURE/INSTALLATION/IN-COMING INSPECTION/SERVICE, OUT OF BOX FAILURE? INCOMING INSPECTION - THE ISSUE WAS DISCOVERED BY HOUSEKEEPING THE DAY AFTER DELIVERY. IF THE DEVICE WAS NOTICED DURING PROCEDURE, WAS THE PROCEDURE COMPLETED SUCCESSFULLY? NOT APPLICABLE, HOUSEKEEPING WAS INSPECTING THE NEW UNITS. WAS THERE ANY MEDICAL INTERVENTION REQUIRED? NO. DID THE ISSUE RESULT IN ANY DELAY OR PROLONGATION TO ANY MEDICAL PROCEDURE/TREATMENT/THERAPY? NO.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ISOFLEX MATTRESS WAS SATURATED WITH MOISTURE AND THE FIRE BARRIER WAS WET AND STAINED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOFLEX 35X84X6 NYLON MATTRESS FNM STRYKER CORP DBA GAYMAR 2800100010 NA

    Patients

    Seq Age Sex Outcome Treatment
    1