BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3241379 · Received July 22, 2013

    Report

    Report Number
    2210968-2013-14010
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    August 26, 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). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH TVH WITH BSO, PELVIC ADHESIOLYSIS, AND ANTERIOR AND POSTERIOR COLPORRHAPHY DUE TO FOURTH DEGREE UTERINE VAGINAL PROLAPSE, THIRD DEGREE CYSTOCELE AND RECTOCELE, AND SUI. FOLLOWING INSERTION, THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, URINARY PROBLEMS, BLEEDING, DYSPAREUNIA, AND VAGINAL SCARRING. A MESH REVISION/REMOVAL WAS PERFORMED ON (B)(6) 2011. (B)(4) ¿ URINARY PROBLEMS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 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
    341230 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 1396005

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention