BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3214080 · Received July 9, 2013

    Report

    Report Number
    2210968-2013-12680
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    November 23, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION PATIENT EXPERIENCED MIXED INCONTINENCE AND CYSTOCELE. IT WAS REPORTED THAT PATIENT UNDERWENT RIGID CYSTOURETHROSCOPY ON (B)(6) 2013 BY DR. (B)(6) HOSPITAL.

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE AND A MESH WAS IMPLANTED CONCURRENTLY WITH LAPAROTOMY, TAH/LSO, POSTERIOR REPAIR, AND CYSTOSCOPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2003 AND MESH WAS IMPLANTED CONCURRENTLY WITH TOTAL ABDOMINAL HYSTERECTOMY, LEFT SALPINGO-OOPHORECTOMY, CYSTOSCOPY, DUE TO IRREGULAR UTERINE BLEEDING, OVARIAN CYSTS, STRESS URINARY INCONTINENCE, CYSTOCELE/RECTOCELE, AND HYPERMOBILE URETHRA. 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
    312656 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 1060687

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention