BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3223625 · Received July 12, 2013

    Report

    Report Number
    2210968-2013-12997
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    August 12, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT INCISION AND DRAINAGE OF LEFT LABIA MAJORA ABSCESS ON (B)(6) 2010. THE PATIENT UNDERWENT EXCISION OF ERODED TVT TAPE ON PREVAGINAL WALL ON (B)(6) 2012. THE PATIENT UNDERWENT ABSCESS WITH FISTULA SURGERY ON (B)(6) 2012 DUE TO RECURRENT LEFT VULVAR ABSCESS WITH A VULVAR FISTULA. THE PATIENT UNDERWENT REMOVAL OF RESIDUAL MESH ON (B)(6) 2013 DUE TO EROSION. THE PATIENT UNDERWENT BURCH PROCEDURE ON (B)(6) 2013 DUE TO SUI. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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 THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND A MESH WAS IMPLANTED CONCURRENTLY WITH REPAIR OF RECTOCELE AND PERINEOPLASTY DUE TO SYMPTOMATIC GENITAL RELAXATION SYNDROME AND SUI.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 7/26/2016.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324406 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 1190531

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention