BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOP COVER M1000S34G

    MDR report key: 2424885 · Received January 11, 2012

    Report

    Report Number
    1313850-2012-00012
    Event Type
    Other
    Date Received
    January 11, 2012
    Date of Event
    November 15, 2011
    Report Date
    December 14, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: POTENTIAL FLUID INGRESS (AT FILING DATE, NO ADD'L INFO IS KNOWN OTHER THAN WHAT WAS INITIALLY REPORTED; IF STAINING IS DETERMINED TO NOT BE ATTRIBUTABLE TO FLUID INGRESS UPON INVESTIGATION COMPLETION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS NECESSARY).

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE DISTRIBUTOR THAT: "STAINS APPEARED ON THE COVER AFTER TESTS AT THE HOSPITAL. THE STAINS CANNOT BE WASHED." NO PT INVOLVEMENT OR ADVERSE CONSEQUENCE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOP COVER M1000S34G MATTRESS COVER FNM STRYKER CORP DBA GAYMAR H101058001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1