BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT SYSTEM

    MDR report key: 3202327 · Received June 27, 2013

    Report

    Report Number
    MW5030723
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    April 19, 2013
    Report Date
    June 25, 2013
    Manufacturer
    JOHNSON AND JOHNSON - ETHICON
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAD TVT MESH PUT IN (B)(6) 2013 AND I HAVE BEEN IN CONSTANT PAIN SINCE. I WAS IN HORRIBLE PAIN, COULDN'T SIT OR STAND. I ASKED FOR IT TO BE TAKEN OUT AND THE DOCTOR PARTIALLY REMOVED IT ON (B)(6) /2013. HE LEFT THE ENDS IN. HE WENT BACK IN ON (B)(6) 2013, BUT HE DOESN'T KNOW WHAT HAPPENED TO THE ENDS. I AM STILL IN PAIN, TRYING TO GET HELP FOR POSSIBLE NERVE DAMAGE OR NERVE ENTRAPMENT FROM THE LEFT OVER MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293195 GYNECARE TVT SYSTEM NONE OTN JOHNSON AND JOHNSON - ETHICON 810081 36369533

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention| S 600MG IBUPROFEN| PRILOSEC