BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3162762 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-10116
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    November 13, 2017
    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). STRESS URINARY INCONTINENCE. DYSPAREUNIA. EMOTIONAL DAMAGES. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: (B)(4) 2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED STRESS URINARY INCONTINENCE, DYSPAREUNIA, AND URINARY TRACT INFECTIONS. THE PATIENT ALSO EXPERIENCED MENTAL/EMOTIONAL DAMAGES; THE MESH HAS CAUSED A TRAUMATIC EXPERIENCE AND HAS CAUSED SUFFERING. INTIMACY BETWEEN THE PLAINTIFF AND HER HUSBAND HAS BEEN AFFECTED DUE TO SEVERE PAIN DURING SEXUAL INTERCOURSE. THIS HAS CAUSED MUCH STRESS. PATIENT EXPERIENCES INCONTINENCE AND CAUSES HER EMBARRASSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262361 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3518878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention