BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE BIO - A HERNIA PLUG

    MDR report key: 3161621 · Received June 7, 2013

    Report

    Report Number
    MW5030479
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    February 1, 2011
    Report Date
    June 7, 2013
    Manufacturer
    W.L. GORE ASS. INC
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THAT 2 1/4 YEARS AGO HE HAD A GORE BIO - A HERNIA PLUG IMPLANTED DURING HERNIA REPAIR SURGERY. HE HAD CONSTANT GROIN PAIN AFTER THE SURGERY AND ABOUT A MONTH AFTER SNEEZED AND FELT A POP. HE REPORTED THE INCIDENT TO HIS PHYSICIAN AND HE TOLD HIM THAT NOTHING WAS WRONG. LATER HE HAD A SECOND OPINION AND THIS SURGEON ALLEGEDLY SUSPECTS THAT THE POP MAY HAVE INDICATED AN ISSUE WITH THE PLUG. TWO YEARS AFTER IMPLANTATION HE BEGAN HAVING BOWEL ISSUES TO INCLUDE CONSTIPATION. HIS HERNIA HAD ALSO RETURNED. NINE WEEKS AGO HE HAD A LAPAROSCOPIC HERNIA REPAIR. DURING THE PROCEDURE THE SURGEON SAW NO SIGN OF THE PLUG. THE PLUG IS SUPPOSED TO ABSORB 6 MONTHS AFTER IMPLANTATION. THE PT'S BOWEL ISSUES SUBSIDED AFTER THE REPAIR BUT HE CONTINUES TO HAVE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252352 GORE BIO - A HERNIA PLUG HERNIA PLUG FTL W.L. GORE ASS. INC 8349952

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention