BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRT MATTRESS W/O PENDANT

    MDR report key: 2140772 · Received June 15, 2011

    Report

    Report Number
    1313850-2011-00142
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE MATTRESS HAD A BAD ODOR DUE TO ALLEGED FLUID INTRUSION. THERE WAS PT INVOLVEMENT, HOWEVER, NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPRT MATTRESS W/O PENDANT MATTRESS IKY STRYKER CORP DBA GAYMAR 2950200000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1