BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT DEVICE

    MDR report key: 12614424 · Received October 12, 2021

    Report

    Report Number
    2210968-2021-09521
    Event Type
    Injury
    Date Received
    October 12, 2021
    Date of Event
    July 18, 2021
    Report Date
    September 15, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031000322
    PMA / PMN Number
    K012628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (B)(4). A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA FOR LOT 2905686 AND PRODUCT CODE 810041B. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON AN UNKNOWN DATE AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY FREQUENCY, A SLOW STREAM AND LOWER ABDOMINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513718 GYNECARE TVT DEVICE MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 810041B 2905686 10705031000322

    Patients

    Seq Age Sex Outcome Treatment
    1