BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3223764 · Received July 12, 2013

    Report

    Report Number
    2210968-2013-13033
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    April 11, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ANTERIOR VAGINAL REPAIR, RECTOCELE REPAIR AND SACROSPINOUS VAGINAL SUSPENSION; DUE TO VAGINAL PROLAPSE AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2012 DUE TO EROSION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, BLEEDING, DYSPAREUNIA, VAGINAL SCARRING AND OTHER NON SPECIFIC OUTCOMES. (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    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

    IT WAS REPORTED THAT PATIENT UNDERWENT DIAGNOSTIC LAPAROSCOPY, LAPAROSCOPIC EXCISION OF MESH, VAGINAL REMOVAL OF MESH AND CYSTOURETHROSCOPY ON (B)(6) 2013 DUE TO CHRONIC PELVIC PAIN, DYSPAREUNIA, AND HISTORY OF PLACEMENT OF TRANSVAGINAL MESH IN THE ANTERIOR COMPARTMENT AND A SLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WERE 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
    323176 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 2931844

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention