BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT-AA ABDOMINAL

    MDR report key: 3241386 · Received July 22, 2013

    Report

    Report Number
    2210968-2013-14007
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    July 9, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 AND MESH WAS IMPLANTED DUE TO SUI. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED MESH EROSION, EXTRUSION, BLEEDING, CHRONIC ABDOMINAL AND PELVIC PAIN, AND VAGINAL SCARRING. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2006 (RECURRENCE OF URINARY INCONTINENCE, BURCH PROCEDURE AND EXPOSED MESH). IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF OLD MESH AND IMPLANTATION OF AN UNKNOWN MESH ON 06/01/2006. IT WAS ALSO REPORTED THAT PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2006 DUE TO CHRONIC PAIN, BLEEDING, MESH EXTRUSION AND EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 INTERNAL TISSUES, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340893 GYNECARE TVT-AA ABDOMINAL MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 1328231

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention