BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBTURATOR SYSTEM

    MDR report key: 3242699 · Received July 23, 2013

    Report

    Report Number
    2210968-2013-14138
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    October 10, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT MESH WAS IMPLANTED ON (B)(6) 2012 TO TREAT DYSPAREUNIA AND LIKELY SECONDARY TO PRIOR SLING URETHROPEXY WITH CONCURRENT PRIOR SLING REMOVAL. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A PREVIOUS PROCEDURE ON 10/08/2003 AND A SABER SLING WAS IMPLANTED INTO THE PATIENT DUE TO STRESS URINARY INCONTINENCE. IT WAS FURTHER REPORTED THAT MESH WAS REMOVED ON (B)(6) 2004 AND A PORCINE SUBURETHRAL SLING BY AMERICAN MEDICAL SYSTEMS WAS IMPLANTED INTO THE PATIENT. ON (B)(6) 2012, THE MESH WAS REMOVED AND MESH WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2012 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
    342746 GYNECARE TVT OBTURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3633200

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention