BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD MARLEX HERNIA MESH (SIZE 3 X 6 IN)

    MDR report key: 3050311 · Received April 8, 2013

    Report

    Report Number
    MW5029687
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 1, 1998
    Report Date
    April 8, 2013
    Manufacturer
    DAVOL
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO REPORT ADVERSE REACTIONS TO BARD MARLEX HERNIA MESH, VICRYL LIGATURE AND VICRYL SUTURE. PT STATED HE HAS FELT SICK FOR THE LAST 13 YEARS, WITH EXTREME FATIGUE, NO ENERGY AT ALL AND WEAKNESS. HE SAID WHEN HE WAKES UP IN THE MORNING, HE HAS MUSCLE SPASMS AND IS IN EXTREME PAIN, HE SAYS IT FEELS LIKE HE WAS "BEAT UP" IN (B)(6) 2012, HE SAID HE DEVELOPED A SCAB ON HIS UMBILICUS, HIS PHYSICIAN SENT HIM TO A SURGEON WHO TOLD HIM TO WAIT FOR IT TO HEAL. PT SAID IT WOULDN'T HEAL AND THAT HE PULLED A THIN PIECE OF PLASTIC OUT OF THE SCAB. THE PT SHOWED THE PIECE TO HIS DOCTOR, WHO ORDERED A BIOPSY OF THE WOUND. HE SAID THE BIOPSY FOUND FOREIGN BODIES IN THE WOUND AND HE WAS TOLD TO USE ANTIBIOTIC OINTMENT. HE STATED HIS PHYSICIAN PUT STERI-STRIPS OVER THE WOUND, BUT MORE SMALL PLASTIC PIECES CAME PROTRUDING OUT OF THE WOUND. HE FEELS THE MESH IMPLANTED IN HIM IS WHAT HAS BEEN MAKING HIM FEEL SICK FOR THE LAST 13 YEARS. HE FEELS IT'S RUINED HIS LIFE. HE SAID HE IS PLANNING ON HAVING THE MESH REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142513 BARD MARLEX HERNIA MESH (SIZE 3 X 6 IN) HERNIA MESH FTL DAVOL 109100
    142514 VICRYL LIGATURE LIGATURE GAM JOHNSON & JOHNSON
    142515 VICRYL SUTURE SUTURE GAM JOHNSON & JOHNSON

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other