BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 9264348 · Received October 31, 2019

    Report

    Report Number
    2210968-2019-89347
    Event Type
    Injury
    Date Received
    October 31, 2019
    Date of Event
    June 1, 2015
    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 · 1

    (B)(4). A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA FOR LOT 3830636 AND PRODUCT CODE 810081. 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) 2015 AND THE MESH WAS IMPLANTED. POST-OP, THE PATIENT EXPERIENCED URINARY TRACT INFECTION, VAGINAL PAIN, LOWER BACK PAIN, LEG PAIN, PAIN IN THE BUTTOCKS, ACUTE PAIN AND CHRONIC DYSFUNCTION. THE PATIENT ALSO EXPERIENCED DYSPAREUNIA, NEUROMUSCULAR PROBLEMS, DIFFICULTY IN EVACUATING STOOL AND EMOTIONAL STRESS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057283 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3830636 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention