BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT DEVICE

    MDR report key: 12215102 · Received July 22, 2021

    Report

    Report Number
    2210968-2021-06621
    Event Type
    Injury
    Date Received
    July 22, 2021
    Date of Event
    November 16, 2016
    Report Date
    June 23, 2021
    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 3920005 AND PRODUCT CODE 810041B. NO ADDITIONAL INFORMATION IS AVAILABLE. 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 (B)(6) 2016 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERMANENT HIP PAIN, SIDE DIFFICULTIES, DIFFICULTIES DURING SEXUAL INTERCOURSE, DIFFICULTY IN SITTING FOR A LONG TIME BECAUSE OF PAIN, THE FEEL OF MOVEMENT IN THE STOMACH, STOPPAGE OF WORK FOR FATIGUE, PAIN IN SHOULDER, AS WELL AS HIP, RIGHT SIDE, AND RIGHT FOOT. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE VAGINA, AND CONSTANT HEAT AS IF THE PATIENT WAS WEARING PANTIES TOO TIGHT ALL THE TIME. IT WAS REPORTED THAT THE PAIN WAS CONSTANT. IT WAS ALSO REPORTED THAT THE PATIENT WAS LIMITED TO SHORT WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106112 GYNECARE TVT DEVICE MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 810041B 3920005 10705031000322

    Patients

    Seq Age Sex Outcome Treatment
    1