BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3232679 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-13593
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    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). IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON ALONG WITH LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY/BILATERAL SALPINGO-OOPHORECTOMY, CULDOPLASTY, COLPOSUSPENSION AND CYSTOURETHROSCOPY DUE TO STRESS URINARY INCONTINENCE AND URINARY URGENCY. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED RECURRENT URINARY TRACT INFECTIONS AND YEAST INFECTIONS, MESH EROSION AND EXPOSURE, CHRONIC HIP, PELVIC AND VAGINAL PAIN, INFLAMMATION OF PELVIC AREA, BOWEL PROBLEMS, FECAL IMPACTION, AND CONSTIPATION RELATED TO RECTOCELE WHICH DEVELOPED POST OPERATIVE, PAINFUL BOIS ON UPPER THIGHS, URINARY FREQUENCY DAY AND NIGHT, AND RECURRENT INCONTINENCE. IT WAS REPORTED THAT PATIENT THERE WAS EVIDENCE OF MESH EROSION ON THE RIGHT SIDE OF THE URETHRA ON (B)(6) 2004.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) /2004 AND MESH WAS 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
    333107 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 1145185

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention