BEUDAMED
    FDA Adverse Event Other Summary report: N

    MESH

    MDR report key: 888560 · Received July 27, 2007

    Report

    Report Number
    MW5003209
    Event Type
    Other
    Date Received
    July 27, 2007
    Date of Event
    January 1, 2001
    Report Date
    July 27, 2007
    Manufacturer
    W. L. GORE
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD AN ALLERGIC REACTION TO THE GORE-TEX PRODUCT SHE HAD PUT IN MY NOSE. DR CALLED W. L GORE, WHICH THEY INFORMED HER THAT THEIR PRODUCT DOES NOT CAUSE ANY ALLERGIC REACTIONS. FROM THAT DISCUSSION DR MUST HAVE BELIEVED THEM BECAUSE SHE OPERATED ON MY NOSE AGAIN AND PUT MORE GORE-TEX IN MY BODY IN ADDITION TO WHAT WAS ALREADY PUT IN DURING THE FIRST OPERATION. AFTER A FEW MONTHS HAD GONE BY, I GOT A SMALL LUMP ON THE TOP LEFT SIDE OF MY NOSE. AT THAT TIME, I REALLY WASN'T CONCERNED AND JUST THOUGHT IT WAS A PIMPLE COMING UP, BECAUSE I DID GET ACNE FROM TIME TO TIME. AS TIME WENT BY, THE LUMP ON MY NOSE STARTED TO GET BIGGER, EVENTUALLY BURSTING AND DRAINING FLUID. I WAS FORCED TO WEAR SMALL BAND-AIDES TO ABSORB THE FLUID AND TO KEEP THE HOLE COVERED AND CLEAN, NOT MENTION TO COVER THE EYE-SORE OF AN OPEN WOUND THROUGH THE SKIN IN A HIGHLY VISIBLE PLACE ON MY FACE. AS TIME WENT ON, THE HOLE STEADILY BECAME LARGER. I DECIDED I WOULD NOT GO BACK TO DR BECAUSE OF A DISAGREEMENT BETWEEN HER AND MYSELF. BETWEEN THE END OF 2002 AND THE BEGINNING OF 2004, I WENT TO SEE 4 DIFFERENT DOCTORS AND NOT ONE OF THEM KNEW WHAT WAS HAPPENING TO MY NOSE. TOWARDS THE BEGINNING OF 2004, MY NOSE STARTED TO GIVE OFF A SOUR SMELL LIKE MEAT OR FLESH ROTTING. SHORTLY AFTERWARDS, A PIECE OF MY NOSE BONE FELL OUT AND THE SIDE OF MY NOSE WITH THE HOLE STARTED TO COLLAPSE. MY HUSBAND AND I STARTED TO PANIC BIG TIME BECAUSE WE HAD NO IDEA WHAT WAS CAUSING THIS TO HAPPEN. MY FAMILY DOCTOR EVENTUALLY FOUND A SPECIALIST, DR WHICH I WENT TO SEE AT THE CLINIC. DR FOUND OUT THAT THE CAUSE OF MY SKIN DECAY, THE FOUL ODOR, ETC, WAS THE GORE-TEX PRODUCT THAT DR HAD PUT IN MY NOSE, TWICE. DR COULD NOT DO ANYTHING WITH MY NOSE BECAUSE HIS SPECIALTY DIDN'T INCLUDE RECONSTRUCTION OF THE NOSE AREA. STILL GOING THROUGH OPERATIONS..HTTP://HOMETOWN.AOL.COM/__121B_C29NRJETPLFC/MUS1D+MEWHHBIHB62O7, PICTURE OF MY NOSE. DIAGNOSIS OR REASON FOR USE: BROKEN NOSE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH MESH FTL W. L. GORE

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other JUST THE MESH PUT IN MY NOSE.