BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRT W/O PENDANT W/DARTEX

    MDR report key: 2760316 · Received September 20, 2012

    Report

    Report Number
    1313850-2012-00295
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Date of Event
    August 24, 2012
    Report Date
    August 27, 2012
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    FMW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE CUSTOMER FOUND THAT THERE IS A SIGNIFICANT DISCOLORATION ON THE FOAM PORTION OF THE MATTRESS NEAR THE LAL TUBING. IT IS ALLEGED THAT ON INITIAL INSPECTION THIS AREA APPEARED TO BE A LITTLE MOIST AS WELL. NO PG INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPRT W/O PENDANT W/DARTEX MATTRESS FMW STRYKER CORP DBA GAYMAR 2950200002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1