BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBTURATOR SYSTEM

    MDR report key: 3221023 · Received July 11, 2013

    Report

    Report Number
    2210968-2013-12837
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 16, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, URINARY AND BOWEL PROBLEMS, ORGAN PERFORATION, RECURRENCE, BLEEDING, DYSPAREUNIA AND VAGINAL SCARRING. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED ALONG WITH CONCURRENT POSTERIOR REPAIR, PERINEORRHAPHY, ANAL SPHINCTER REPAIR, AND INTRAOPERATIVE CYSTOSCOPY DUE TO POSTERIOR VAGINAL PROLAPSE. NO ADDITIONAL INFORMATION WAS PROVIDED. 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, FISTULAE, RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING AND UNDERWENT VULVAR BIOPSY ON (B)(6) 2008 DUE TO RETROPERITONEAL PERIAORTIC MASS. IT WAS REPORTED THAT PATIENT UNDERWENT VAGINECTOMY AND HEMORRHOIDECTOMY ON (B)(6) 2011. IT WAS REPORTED THAT PATIENT UNDERWENT WIDE LOCAL EXCISION OF THE RIGHT LABIA MAJORA AND LABIA MINORA, PERIANAL BIOPSIES, AND VULVAR COLPOSCOPY ON (B)(6) 2015 DUE TO RECURRENT VULVAR INTRAEPITHELIAL NEOPLASIA, ANAL CONDYLOMA NOT RESPONDING TO TRICHLOROACETIC ACID, AND HISTORY OF VULVAR CANCER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2001 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
    320979 GYNECARE TVT OBTURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 2933520

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention