BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TEX

    MDR report key: 1882013 · Received October 20, 2010

    Report

    Report Number
    MW5017895
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    June 20, 1998
    Report Date
    October 20, 2010
    Manufacturer
    GORETEX
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HERNIA REPAIR I BELIEVE WAS GORE-TEX TYPE MESH. I HAVE HAD CONTINUED HEALTH PROBLEMS SINCE. I HAVE BEEN TO SEVERAL DOCTORS ONE OF WHICH DREW BLOODY FLUID FROM MY ABDOMEN -ALMOST A QUART- AND SAID IT WOULD HEAL, BUT IT HAS NOT. ANOTHER SURGEON SAID I WOULD HAVE TO HAVE ABDOMINAL RECONSTRUCTION WHICH WOULD BE VERY DANGEROUS. I AM AT THE END OF MY ROPE. CAN YOU HELP WITH INFO ON ANY RECALLS OF GORETEX OR OTHER HERNIA REPAIR PATCHES. THE ORIGINAL SURGEON SAID I HAD THE LARGEST PATCH HE HAS EVER PERFORMED. IT COVERS MY ENTIRE ABDOMEN. THANK YOU. DATES OF USE: (B)(6) 1997 -- (B)(6) 2009. DIAGNOSIS OR REASON FOR USE: VENTRAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TEX MESH FTL GORETEX

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Life Threatening| R