BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 14604797 · Received June 6, 2022

    Report

    Report Number
    2210968-2022-04320
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    January 1, 2022
    Report Date
    June 6, 2022
    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
    NJ, US
    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. ANALYSIS SUMMARY: NEUCHÂTEL TEAM RECEIVED FOR EVALUATION A TVTO DEVICE (PRODUCT CODE 810081), BATCH 3939834. THE PRODUCT WAS DECONTAMINATED AND WELL PACKAGED. THE RECEIVED DEVICE WAS MANIPULATED AS ORIGINAL PACKAGING AND SOME COMPONENTS WERE MISSING. ONLY ONE PART OF BLUE MESH WAS RETURNED WITH ONE WHITE PLASTIC NEEDLE AND ONE GUIDE. THE MESH WAS CUT. THE TIP OF THE WHITE PLASTIC NEEDLE PRESENT A DAMAGE, THE TIP IS BROKEN. NO OTHER DAMAGES WERE OBSERVED. THE DEFECT IDENTIFIED IS NOT LINKED TO A MANUFACTURING ISSUE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. WHEN THE DEVICE WAS OPENED TO BE USED DURING THE PROCEDURE, ONE OF THE WHITE PLASTIC TIPS ON THE END WAS CRACKED/BROKEN WHEN TAKEN OUT OF THE BOX. THE STAFF OPENED ANOTHER DEVICE WHICH WAS UNBROKEN UPON INSPECTION AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SECOND OPENED DEVICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227140 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 810081 3939834 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown