BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARLEX

    MDR report key: 1982209 · Received February 3, 2011

    Report

    Report Number
    MW5019304
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    September 21, 2008
    Report Date
    February 3, 2011
    Manufacturer
    NA
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2008, HAD HERNIA OPERATION. MARLEX POLYPROPYLENE HERNIA MESH WAS IMPLANTED WITH PLUG. ON (B)(6) 2008, I HAD BURNING SENSATION ALL OVER, FELT HOT, AND WAS BLACK AND BLUE FROM MY BELLY BUTTON TO MY KNEES, BI-LATERALLY. MY SURGICAL DRESSING WAS ALSO SOAKED WITH BLOOD. I CALLED SURGEON'S OFFICE AND GOT NO REPLY. I SAW MY GP, AND HE REPORTED TO SURGEON, AND CHANGE DRESSING. I REPORTED IT TO THE ATTENDING SURGEON, DR. (B)(6), WHO IMPLANTED THE "MESH", ABOUT 10 DAYS AFTER THE SURGERY. I WAS SENT TO NEUROLOGIST, AND PUT ON NEURONTIN FOR PAIN WITH NO RELIEF. NEXT EIGHT MONTHS, SEVERAL VISITS TO VARIOUS DRS WITH SEVERAL TESTS, AND CAT-SCANS WITH CLEAR DIAGNOSES. WENT TO (B)(6) CLINIC, (B)(6). SEVERAL TESTS AND C-SCANS WITH NO CLEAR DIAGNOSES ENDING IN (B)(6) 2010. I WAS ON MEDS, NEURONTIN, AND CLONAZEPAM FOR PAIN WITH NO RELIEF. I WAS EXTREMELY UNCOMFORTABLE. THROUGH A FRIEND, I GOT THE NAME A FELLOW CLOSE TO HOME WHO HAD PROBLEMS WITH POLYPROPYLENE MESH. REFERRED ME TO (B)(6) HOSP. POLYPROPYLENE MESH AND PLUG WAS SURGICALLY REMOVED ON (B)(6) 2010. IMMEDIATE IMPROVEMENT, AND I AM PRESENTLY SLOWING HEALING. PAIN IS INTERMITTENT, AND STILL SOMETIMES SEVERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARLEX MARLEX POLYPROPYLENE HERNIA MESH, LARGE FTL NA NO INFO GIVEN OF NO INFO GIVEN OF

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention| S NONE OTHER THAN HERNIA PLUG.