BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3233834 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-13673
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    September 21, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    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 A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE, CYSTOCELE, URINE LEAKAGE WITH COUGHING AND SNEEZING. THE PATIENT EXPERIENCED VAGINAL BURNING AND ITCHING, INABILITY TO URINATE WHILE SEATED, PAINFUL INTERCOURSE, RECURRENT URINARY LEAKAGE AND INCONTINENCE, KNEE PAIN FROM HAVING TO STAND WHILE URINATING AND INFECTION. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL FOR TWO LARGE PIECES OF MESH COMING OUT, VAGINAL BURNING, PALPABLE KNOTS BY MESH, AND WORSENING INFECTIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    .

    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
    334515 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 1129552

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention