BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMSH PS 4INX6IN

    MDR report key: 20578885 · Received October 31, 2024

    Report

    Report Number
    2210968-2024-11291
    Event Type
    Injury
    Date Received
    October 31, 2024
    Date of Event
    June 4, 2004
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    UDI-DI
    10705031037731
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED. ON (B)(6) 2007, EROSION OF A MESH WEB WAS NOTED IN THE PATIENT WHO HAS ALREADY HAD EROSION OF THIS PLAQUE. UNDER LOCAL ANESTHESIA, THIS IS AN EXHIBITION ON 1/3 CM3, THE CANVAS WILL BE CAUGHT AND THE VAGINAL WALL RESECTED AROUND THIS EXHIBITION. ABOUT 1/3 CM3 WILL BE REMOVED AND THEN THE VAGINAL WALL WILL BE CLOSED WITH VICRYL 2/0. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067119 GYNECARE GYNEMSH PS 4INX6IN MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC. TCE950 10705031037731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention