BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT SECUR SYSTEM

    MDR report key: 4933386 · Received July 22, 2015

    Report

    Report Number
    2210968-2015-03521
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    November 15, 2007
    Report Date
    March 4, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION CODE: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007, AND A MESH WAS IMPLANTED DUE TO SUI. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2008, DUE TO MESH EROSION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2010, DUE TO MESH EROSION AND DYSPAREUNIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2012, DUE TO DYSPAREUNIA AND VAGINAL PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A MESH WAS IMPLANTED DUE TO URINARY INCONTINENCE. THE PATIENT SUFFERED FROM PAIN AND DYSPAREUNIA AND HAS UNDERGONE VARIOUS SURGICAL PROCEDURES IN AN ATTEMPT TO REMOVE THE MESH, EXPERIENCES PHYSICAL, PSYCHOLOGICAL AND EMOTIONAL PAIN, SUFFERING AND HAS SUSTAINED PERMANENT AND DEBILITATING INJURIES. (B)(6) FOR REPORT ON THE SECOND TVTS DEVICE LOT 3190447.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474362 GYNECARE TVT SECUR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC PAH ETHICON INC. UNK 3057512

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention