BEUDAMED
    FDA Adverse Event Summary report: N

    JOHNSON & JOHNSON - ETHICON- MEDIUM MESH

    MDR report key: 2973869 · Received February 13, 2013

    Report

    Report Number
    MW5029030
    Date Received
    February 13, 2013
    Date of Event
    August 25, 2011
    Report Date
    February 13, 2013
    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

    I HAD A BILATERAL INGUINAL HERNIA SURGERY. AT THE TIME OF THE OPERATION, I WAS NOT IN PAIN, MORE OF A DISCOMFORT ALL THE TIME WITH TWO LUMPS IN MY GROIN. I WAS RECONFIRMED OF WHAT I ALREADY KNEW, MORE PROBLEMS DOWN THE ROAD IF IT WASN'T REPAIRED AND THIS SCARED ME TO THE POINT THAT I DECIDED TO HAVE IT DONE. I WAS FIXED WITH ETHICON UHSM MESH. AFTER RECOVERING FROM EXCRUCIATING PAIN FROM THE SURGERY, CERTAIN PAINS NEVER WENT AWAY AND NEW PAINS BEGAN TO APPEAR IN MY GROIN AREA AS WELL AS MY TESTICLES. NOT SURE HOW TO EXPLAIN PAIN BESIDES IMAGINING BEING KICKED BY A HORSE IN THE GROIN AND SHARP STABBING PAINS IN TESTICLES ON AN EVERY DAY BASIS. AFTER A FEW SCRIPTS FOR PAIN, I WAS SENT TO PAIN MANAGEMENT FOR NERVE BLOCK INJECTIONS AND EXTREMELY EXPENSIVE AND STRONG PAIN KILLERS. I AM ON 75MG OF MORPHINE EVERYDAY JUST TO MASK THE PAIN, THE QUALITY OF LIFE IS GONE AS I KNOW IT. INJECTIONS WOULD RELIEVE PAIN FOR A COUPLE DAYS AND THE BACK WITH THE HORSE KICKING AGAIN. I HAVEN'T EXPERIENCED THE KIND OF PAIN I AM IN OR HAVE DEALT WITH IN THE PAST. ALL ROADS POINT TO THE MESH IMPLANT I HAD. I WOULD RECOMMEND TAKING THIS MESH OFF THE MARKET BEFORE MORE PEOPLE HAVE TO SUFFER THE WAY I AM TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64083 JOHNSON & JOHNSON - ETHICON- MEDIUM MESH HERNIA MESH FTL UHSM

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Congenital Anomaly| H| L| O| R| S