BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3221735 · Received July 11, 2013

    Report

    Report Number
    2210968-2013-12884
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    November 3, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND A MESH WAS IMPLANTED, CONCURRENTLY WITH A PUBOVAGINAL SLING, CYSTOSCOPY DUE TO SUI, MIXED URINARY INCONTINENCE, AND URETHRAL HYPERMOBILITY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: (B)(4) 2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS 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
    319651 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 2910355

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PUBOVAGINAL SLING