BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT-AA ABDOMINAL

    MDR report key: 3163179 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-10143
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    April 22, 2016
    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).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, BLEEDING, AND DYSPAREUNIA. IT WAS REPORTED THAT PATIENT UNDERWENT TRANSVAGINAL MESH EXCISION WITH CYSTOSCOPY ON (B)(6) 2014 DUE TO DYSPAREUNIA. IT WAS REPORTED THAT PATIENT UNDERWENT EXCISION OF VAGINAL MESH, EXCISION OF GRANULATION TISSUE OF THE VAGINAL CUFF AND A VAGINAL POLYP ON (B)(6) 2009 DUE TO DYSPAREUNIA, VAGINAL BLEEDING, MESH EROSION, AND PAIN. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT MESH WAS IMPLANTED ALONG WITH VAGINAL HYSTERECTOMY, TVT, AND CYSTOSCOPY DUE TO MENORRHAGIA, DYSMENORRHEA, SYMPTOMATIC UTERINE FIBROIDS, STRESS URINARY INCONTINENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION OF THE MESH THE PATIENT EXPERIENCED PAIN, EROSION, URINARY PROBLEMS, BLEEDING, AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION IN 2007. (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. THE PATIENT 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
    264517 GYNECARE TVT-AA ABDOMINAL MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 1130976

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention