BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 12200405 · Received July 20, 2021

    Report

    Report Number
    2210968-2021-06519
    Event Type
    Injury
    Date Received
    July 20, 2021
    Report Date
    June 23, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031000346
    PMA / PMN Number
    K033568
    Removal / Correction Number
    N/A
    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 3758057 AND PRODUCT CODE 810081. 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 AN UNKNOWN DATE AND THE MESH WAS IMPLANTED. IT WAS REPORTED PATIENT EXPERIENCED CHRONIC FATIGUE, AUTOIMMUNE DISEASE, LOWER BACK PAIN, KNEE PAIN, WEAKNESS, GROIN PAIN, AND JOINT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093976 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 810081 3758057 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1