BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT DEVICE

    MDR report key: 9264006 · Received October 31, 2019

    Report

    Report Number
    2210968-2019-89346
    Event Type
    Injury
    Date Received
    October 31, 2019
    Date of Event
    May 29, 2019
    Report Date
    October 7, 2019
    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). A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA FOR LOT 3832826 AND PRODUCT CODE 810041B. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2017 AND THE MESH WAS IMPLANTED. POST-OP, THE PATIENT EXPERIENCED URINARY INFECTIONS, CONSTIPATION AND PAIN IN THE PELVIS, HIPS AND LEGS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057818 GYNECARE TVT DEVICE MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3832826 10705031000322

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention