BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON INC

    MDR report key: 1287085 · Received January 11, 2009

    Report

    Report Number
    MW5009597
    Event Type
    Injury
    Date Received
    January 11, 2009
    Date of Event
    February 17, 2008
    Report Date
    January 11, 2009
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2008, I WENT TO THE SURGEON TO HAVE BILATERAL INGUINAL HERNIA REPAIR. SINCE THEN, I'VE HAD SEVERE BACK PAIN, GROIN PAIN, REDNESS AND SWELLING NEAR INCISION SITE, FEVERS, AND SHARP PAINS IN ABDOMEN. WENT BACK TO DOCTORS AND WAS TOLD TO TAKE 400MG MOTRIN, AND HAVE BEEN SENT TO PAIN MANAGEMENT. NOTHING HELPED. ADMITTED TO EMERGENCY ROOM IN EARLY 2009 AND GIVEN PAIN MEDICATION THROUGH AN IV TO HELP ME WITH THE PAIN. AT THIS POINT I'VE WENT FROM 40HR WORK WEEK TO A 16HR WEEK FROM NOT BEING ABLE TO BEND, LIFT, OR WALK WITHOUT EXTREME PAIN. WENT BACK TO SURGEON AND HE GAVE ME TWO SHOTS OF PREDNISONE IN MY GRION REGION AND SAID I CAN COME BACK EVERY MONTH TO SEE IF IT HELPS THE PAIN. NOT SURE IF MESH MOVED AND NERVE ENTRAPMENT, BUT CAN'T HAVE ANY CLOTHING TOUCH SCARS FROM SKIN SENSITIVITY. PROLENE MESH FROM ETHICON INC WAS USED. PRODUCT CODE: PMH SIZE 6X6. CONSIDERING A SECOND SURGERY WITH A DIFFERENT BRAND OF MESH. DIAGNOSIS OR REASON FOR USE: BILATERAL HERNIA SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON INC PROLENE MESH FTL JOHNSON & JOHNSON

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| S