BEUDAMED
    FDA Adverse Event Other Summary report: N

    MARLEX PATCH

    MDR report key: 863993 · Received June 7, 2007

    Report

    Report Number
    MW5002542
    Event Type
    Other
    Date Received
    June 7, 2007
    Date of Event
    February 1, 2007
    Report Date
    June 7, 2007
    Manufacturer
    MARLEX
    Product Code
    FTL
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT SAYS THAT ABOUT 10 YEARS AGO, HE HAD SPLENECTOMY FOLLOWING A MOTOR VEHICLE ACCIDENT. LATER, THE SPLEEN HERNIATED AND A MARLEX PATCH WAS PLACED SOON AFTER, THE PATIENT EXPERIENCED SEVERAL STOMACH SYMPTOMS TO INCLUDE A SOUR TASTE IN HIS MOUTH. HE WAS PLACED ON MINERAL OILS FOR THE PRESUMED DIAGNOSIS OF CONSTIPATION. TWO YEARS AGO, HE WAS HOSPITALIZED FOR RELATED STOMACH SYMPTOMS, BUT NO DIAGNOSIS COULD BE FOUND. IN 2007, HE WAS OPERATED ON AND THE PATCH HAD ADHERED TO HIS INTESTINES. HE FEELS THAT THIS PATCH LIKE THE KUGEL NEEDS TO BE RECALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARLEX PATCH SURGICAL PATCH FOR SPLEEN FTL MARLEX

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR