BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3190774 · Received June 26, 2013

    Report

    Report Number
    2210968-2013-11238
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 29, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE, RECURRENT VAGINAL VAULT PROLAPSE, ANTERIOR MESH EROSION, AND A RECTOCELE AND A MESH WAS IMPLANTED. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF ANTERIOR/POSTERIOR COLPORRHAPHY, MESH REVISION, AND RECTOCELE REPAIR DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS AND RECURRENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF MESH ON 02/06/2006 DUE TO EROSION OF THE MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT MULTIPLE TRIMMINGS ON (B)(6) 2006, (B)(6) 2007. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF THE MESH GRAFT ON (B)(6) 2008 DUE TO MESH EROSION AND INFLAMMATION. (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291568 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 1146180

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention