BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 17818810 · Received September 26, 2023

    Report

    Report Number
    2210968-2023-07063
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    May 11, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031000346
    PMA / PMN Number
    K033568
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. H3 ANALYSIS SUMMARY: NEUCHÂTEL TEAM RECEIVED FOR EVALUATION A TVTO DEVICE (PRODUCT CODE 810081), BATCH 3943164. THE PRODUCT WAS DECONTAMINATED AND WELL PACKAGED. THE RECEIVED DEVICE WAS MANIPULATED AS ORIGINAL PACKAGING IS MISSING. IT WAS RETURNED SOME PARTS OF PRODUCT: PART OF BLUE MESH, NEEDLES, HELICAL PASSERS, WINGED GIDE, LID (FROM PACKAGING). ALL RETURNED COMPONENTS HAVE A LOT OF ORGANIC MATTER AROUND. THE MESH WAS STRETCHED AND CUT. ONE NEEDLE HAS BEEN REMOVED FROM HELICAL PASSER AND IT CAN BE OBSERVED SOME DAMAGES IN THE NEEDLE TIP. NO OTHER DAMAGES WERE OBSERVED. THE OBSERVATIONS MADE DURING THE PRODUCT EVALUATION ARE NOT ALIGNED WITH THE EVENT DESCRIPTION "MESH IS BROKEN WHEN IT IS OPENED", AS THE PRODUCT WAS MANIPULATED AND USED. THEREFORE, THE COMPLAINT IS NOT CONFIRMED. EVENTS OF THIS TYPE ARE TRENDED REGULARLY. 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 AN UROLOGICAL PROCEDURE ON (B)(6) 2023 AND MESH WAS USED. THE MESH WAS BROKEN WHEN IT WAS OPENED. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096638 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3943164 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown