BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 9272670 · Received November 4, 2019

    Report

    Report Number
    2210968-2019-89458
    Event Type
    Injury
    Date Received
    November 4, 2019
    Date of Event
    September 22, 2008
    Report Date
    October 7, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031000346
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA FOR LOT 3182102 AND PRODUCT CODE 810081.

    Additional Manufacturer Narrative · 1

    (B)(4). 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) 2008 AND THE MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT, POST-OP, THE PATIENT EXPERIENCED REPEATED URINARY TRACT INFECTIONS, VAGINAL, HIP, LEG, BACK, AND STOMACH PAIN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068268 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3182102 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention