BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3211483 · Received July 8, 2013

    Report

    Report Number
    2210968-2013-12345
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    November 9, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE; BIL. PARA-VAGINAL REPAIR, ANTERIOR AND POSTERIOR REPAIR, ENTEROCELE REPAIR WITH MESH REINFORCEMENT, BIL. SACROSPINOUS FIXATION AND TRANSOBTURATOR MID-URETHRAL SLING, FOR CYSTOCELE/RECTOCELE AND VAGINAL VAULT PROLAPSE, ON (B)(6) 2010 MESH WERE IMPLANTED INTO THE PATIENT. IT IS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, INFECTION, DYSPAREUNIA, URINARY PROBLEMS AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME. (B)(4).

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2010 DUE TO POP. IT WAS REPORTED THAT MESH WAS IMPLANTED TO TREAT CYSTOCELE AND UTERINE PROLAPSE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE, BIL. PARA-VAGINAL REPAIR, ANTERIOR AND POSTERIOR REPAIR, ENTEROCELE REPAIR WITH MESH REINFORCEMENT, BIL. SACROSPINOUS FIXATION AND TRANSOBTURATOR MID-URETHRAL SLING, DUE TO CYSTOCELE/RECTOCELE AND VAGINAL VAULT PROLAPSE ON (B)(6) 2010. IT IS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, INFECTION, DYSPAREUNIA, URINARY PROBLEMS AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2010 DUE TO POP. IT WAS REPORTED THAT MESH WAS IMPLANTED TO TREAT CYSTOCELE AND UTERINE PROLAPSE.

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 11/11/2016.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT MESH WAS IMPLANTED TO TREAT CYSTOCELE AND UTERINE PROLAPSE. NO ADDITIONAL INFORMATION WAS PROVIDED. 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; BIL. PARA-VAGINAL REPAIR, ANTERIOR AND POSTERIOR REPAIR, ENTEROCELE REPAIR WITH MESH REINFORCEMENT, BIL. SACROSPINOUS FIXATION AND TRANSOBTURATOR MID-URETHRAL SLING, FOR CYSTOCELE/RECTOCELE AND VAGINAL VAULT PROLAPSE, ON (B)(6) 2010 MESH WERE IMPLANTED INTO THE PATIENT. IT IS ALSO REPORTED THAT 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
    309052 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3398075

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention