BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 10553721 · Received September 18, 2020

    Report

    Report Number
    2210968-2020-07077
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    May 6, 2020
    Report Date
    October 27, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031062368
    PMA / PMN Number
    K033568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO FDA: 10/27/2020 CORRECTED INFORMATION: D1, D4, G5, H4 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 10/29/2020 ADDITIONAL INFORMATION: D10, H6 H3 EVALUATION: THE RECEIVED DEVICE WAS MANIPULATED. THE IMPLANT WAS RETURNED WITHOUT THE BLISTER AND LID. IT WAS OBSERVED THAT THE DEVICE WAS NOT IN ITS ORIGINAL STATE BECAUSE THE HELICAL PASSERS, PLASTICS NEEDLES AND MESH WERE PRESENT BUT TOTALLY DISASSEMBLED. ADDITIONALLY, THE MESH WAS CUT AND THE WHITE PLASTIC NEEDLES WERE DIRTY. THE PLASTIC SHEATH WAS DAMAGED WITH CRACKS. THE MESH WAS DAMAGED AT DIFFERENT POINTS AND THE THREE LINES WERE NOT CONTINUOUS ALL ALONG THE MESH. THE DEFECT ON DEVICE SEEN DURING THE PRODUCT EVALUATION IS ALIGNED WITH THE DEFECT DESCRIBED IN THE EVENT DESCRIPTION ("CRASHES ON DEVICE"). THE DEFECT IDENTIFIED IS NOT LINKED TO A MANUFACTURING ISSUE. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA FOR LOT 3935193 AND PRODUCT CODE 810081. 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, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR 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 GYNECOLOGICAL PROCEDURE ON (B)(6) 2020 AND MESH WAS USED. IT WAS REPORTED THAT THE SLING WAS FOUND WITH DEFECT WHEN THE PACKAGE WAS OPENED, WHICH MADE IT IMPOSSIBLE TO BE USED. THE PROCEDURE WAS COMPLETED USING A LIKE DEVICE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020439 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. TVTOML 3935193 10705031062368

    Patients

    Seq Age Sex Outcome Treatment
    1