BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVT EXACT RETROPUBIC SYSTEM

    MDR report key: 18659387 · Received February 7, 2024

    Report

    Report Number
    2210968-2024-01067
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Date of Event
    January 23, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031062375
    PMA / PMN Number
    K132054
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE PROVIDE LOT NUMBER: 3944711. 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.

    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. PHOTO ANALYSIS SUMMARY: NEUCHATEL TEAM RECEIVED FOR EVALUATION THREE PHOTOS OF ONE GYNECARE TVT EXACT PRODUCT CODE TVTRL AND LOT NUMBER 3944711. AN INVESTIGATION WAS PERFORMED ON RECEIVED PRODUCT AND ON THE BATCH RECORD FILE. IT CAN BE OBSERVED IN PHOTOS THAT THE DEVICE WAS OPENED AND MANIPULATED AS THERE WAS NO BOX, NO IFU AND NO TROCAR. IN PHOTOS ONLY THE 2 NEEDLES, ASSOCIATED MESH AND PART OF BLISTER ARE PRESENT. ADDITIONALLY, A LOT OF ORGANIC MATTER CAN BE SEEN ON THE NEEDLES AND MESH. ALSO, IT CAN BE OBSERVED A DAMAGE ON ONE WHITE NEEDLE. THE AREA USED TO TROCAR INSERTION WAS STRETCHED AND TWISTED. NO DAMAGES CAN BE OBSERVED ON THE OTHER WHITE NEEDLE AND ON THE MESH. BASED ON THE EVALUATION, THIS COMPLAINT IS NOT LINKED TO A MANUFACTURING ISSUE. THE PRODUCT WAS CONFORMING TO SPECIFICATIONS AT THE RELEASE. EVENTS OF THIS TYPE ARE TRENDED REGULARLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6)2024 AND MESH WAS USED. DURING SURGERY, ONE OF THE ¿SPEAR SLEEVES¿ GOT STUCK AND PULLED OUT, ON THE WAY OUT OF THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907612 TVT EXACT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3944711 10705031062375

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown