BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON

    MDR report key: 2172225 · Received July 14, 2011

    Report

    Report Number
    MW5021424
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 15, 2007
    Report Date
    July 14, 2011
    Manufacturer
    JOHNSON & JOHNSON / ETHICON
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ETHICON PHS HERNIA MESH PATCH WAS COMING APART ALMOST IMMEDIATELY AFTER INSERTION THIS IS A QUOTE FROM MY DR'S NOTES THAT REMOVED THE MESH. ETHICON PHS MESH WAS PLACED IN ME (B)(6) 2007. AFTER 2 WEEKS, CHRONIC PAIN BECAME WORSE. I SAW MY DR EVERY MONTH OR SO, HE COULD NOT HELP ME. I HELD OUT A YR UNTIL I GOT WISE TO THE FACT HE HAD NO RESOURCES OR ANSWERS FOR ME SO, I SWITCHED DOCTORS. I FELT AS IF A DOZEN FISH HOOKS HAD BEEN THROWN IN ME AND THEN I WAS SEWED UP. I COULD NOT PUT ON A SEAT BELT, WASH MY HAIR, OR EVEN JUICE A CARROT WITHOUT SEVERE PAIN. IN ADDITION, SPERMATIC CHORDS NEVER FUNCTIONED AGAIN PROPERLY SINCE THE MESH WAS PUT IN. STRANGULATED SPERMATIC CHORDS LEFT MY TESTICLES SWOLLEN TO 3 OR 4 TIMES NORMAL SIZE CAUSING SEVERE PAIN AND NAUSEA 24 HRS A DAY. CAN YOU IMAGINE THIS NIGHTMARE? WE NEED HELP! I HAD THE MESH REMOVED IN (B)(6) 2009. TESTICLES STILL DID NOT WORK UNTIL I PAYED FOR A YR OF LOCAL MASSAGE AND ACUPUNCTURE TO COMBAT THE SCAR TISSUE LEFT ON MY SPERMATIC CHORDS. I RECEIVED TREATMENTS FROM DR (B)(6) AT (B)(6) HOSPITAL (B)(6) FOR THIS AND I HAVE ALL THE RECORDS. I COULD NOT WORK DURING THIS TIME AND AS A RESULT LOST AN EXTENSIVE AMOUNT OF MONEY TO THERAPY AND NO INCOME. AT 9 MONTHS AFTER I HAD THE MESH REMOVED I WAS IN A MOTOR ACCIDENT AND THAT RUPTURED BOTH HERNIAS AGAIN DUE TO THE LACK OF TISSUE THAT WAS LEFT AFTER REMOVING THE MESH. THE HERNIA REPAIR WAS DELICATE AND PROVED NOT TO SURVIVE A SERIOUS MOTOR ACCIDENT. IT IS NOW (B)(6) 2011 AND I AM PREPARING TO GO IN FOR MY 6TH OR 3RD DOUBLE HERNIA OPERATION; HOWEVER, YOU WANT TO LOOK AT IT 3 ON EACH SIDE TOMORROW MORNING. I HAVE NOT WORKED IN 4 YRS, I LOST MY WIFE AND DAUGHTER, MY INSURANCE, AND SOON I AM AFRAID I WILL LOOSE MY HOUSE IF I CANNOT GET BACK TO WORK AFTER THIS OPERATION. I USED TO HAVE A WONDERFUL CHARMED LIFE (B)(4) FOR MAJOR MUSIC EVENTS INCLUDING THE (B)(6)... AND TEACHING YOGA AND MEDITATION ALL OVER (B)(6) AND THE COUNTRY. MY THERAPY DATES ARE NOT AVAILABLE BUT, FAR TOO NUMEROUS TO LIST HERE I ATTENDED THERAPY 3 TIMES A WEEK FOR NEARLY 2 YRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON PROLENE HERNIA SYSTEM FTL JOHNSON & JOHNSON / ETHICON NA
    2 ETHICON PROLENE HERNIA SYSTEM FTL JOHNSON & JOHNSON / ETHICON * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R| S