BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 12205050 · Received July 21, 2021

    Report

    Report Number
    2210968-2021-06562
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    May 1, 2016
    Report Date
    June 23, 2021
    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 2894573 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 (B)(6) 2006 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT FOR FOUR YEARS, THE PATIENT EXPERIENCED A LOT OF PAIN IN THE LOWER BACK, AT A CONTINUOUS POINT IN THE BACK LEFT SIDE. IT WAS REPORTED THAT FOR TWO YEARS, THE PATIENT EXPERIENCED AN INTOLERABLE PAIN ON THE LEFT BUTTOCK, SCIATIC NERVE, THIGH AND LEFT KNEE WHICH DESCENDED TO THE HEEL OF THE LEFT FOOT. IT WAS REPORTED THAT THE PATIENT ALSO EXPERIENCED PAIN IN THE GROIN ON THE LEFT SIDE. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED DIFFICULTY SITTING OR STANDING FOR MORE THAN 30 MINUTES. IT WAS REPORTED THAT THE PATIENT HAD WORK STOPPAGE FOR OVER A YEAR. IT WAS ALSO REPORTED THAT AFTER SEVERAL INVESTIGATIONS, THERE STILL WAS NO POSITIVE DIAGNOSIS. IT WAS ALSO REPORTED THAT THE STRIP HAS NOT BEEN EFFECTIVE FOR ABOUT FOUR YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103562 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 810081 2894573 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1