BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3211544 · Received July 8, 2013

    Report

    Report Number
    2210968-2013-12488
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    June 29, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED A COMPLICATION FROM THE MESH SLING OF TRANSOBTURATOR VESSEL BLEEDING, REQUIRING COIL EMBOLIZATION AND REOPERATION TO EVACUATE RETROPERITONEAL CLOT.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO LEAKAGE WHEN JUMPING/LAUGHING AND SUI. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED SEVERE VAGINAL PAIN, BLEEDING, BOWEL PROBLEMS, DIFFICULTY VOIDING, AUTOIMMUNE ISSUES, AND FOREIGN BODY REACTION ISSUES. IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL RETENTION AND VAGINAL RELEASE ON (B)(6) 2010 AND MESH REMOVAL ON (B)(6) 2013.

    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) 2009 AND MESH WAS PLACED INTO THE PATIENT¿S BODY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311481 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3256674

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention