BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT DEVICE

    MDR report key: 9681852 · Received February 7, 2020

    Report

    Report Number
    2210968-2020-00978
    Event Type
    Injury
    Date Received
    February 7, 2020
    Report Date
    February 5, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031000322
    PMA / PMN Number
    K012628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND INDICATES THAT THERE WERE NO QUALITY CONCERNS ASSOCIATED WITH THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT SHE UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2011 AND MEH WAS IMPLANTED, DUE TO HER STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED ADVERSE EVENT. IT WAS REPORTED THAT SHE UNDERWENT REMOVAL SURGERY IN (B)(6) 2018 AND OTHER UNDISCLOSED PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146270 GYNECARE TVT DEVICE MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 810041B 3447234 10705031000322

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention