BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3211461 · Received July 8, 2013

    Report

    Report Number
    2210968-2013-12353
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    April 19, 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): IT WAS REPORTED THAT MESH WAS IMPLANTED DUE TO CYSTOCELE AND URINARY STRESS INCONTINENCE. THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2012.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE CONCURRENTLY WITH CYSTOSCOPY ON (B)(6) 2005 AND MESHES WERE IMPLANTED INTO THE PATIENT. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EROSION, INFECTION, URINARY PROBLEMS, RECURRENCE, VAGINAL SPOTTING AND DYSPAREUNIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WERE IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE 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
    308841 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 1278957

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention