BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3191123 · Received June 26, 2013

    Report

    Report Number
    2210968-2013-11268
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 2, 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, BLEEDING, DYSPAREUNIA AND FOLDED MESH. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION OF VAGINAL MUCOSA ON (B)(6) 2010 DUE TO HEMATOMA AND EXPOSED ANTERIOR VAGINAL MESH 2 ½ WEEKS POST ELEVATE MESH PROCEDURE. IT WAS REPORTED THAT PATIENT UNDERWENT EXCISION OF EXPOSED VAGINAL MESH AND REVISION OF VAGINAL MUCOSA ON (B)(6) 2012 DUE TO EXPOSED VAGINAL MESH, CYSTOSCOPY AND LEFT RETROGRADE PYELOGRAM DUE TO LEFT URETERAL STONE. ON (B)(6) 2012 PATIENT UNDERWENT EXCISION OF EXPOSED VAGINAL MESH DUE TO EXPOSED VAGINAL MESH. I WAS REPORTED THAT PATIENT UNDERWENT EXCISION OF EXPOSED VAGINAL MESH ON (B)(6) 2012 DUE TO EXTREME PAIN AND EXPOSED VAGINAL MESH.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH AND ANTERIOR ELEVATE MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY TO TREAT GRADE III UTERINE PROLAPSE AND CYSTOCELE WITH HYPERMOBILE URETHRA. IT IS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290753 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3422125

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention