BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVT EXACT RETROPUBIC SYSTEM

    MDR report key: 13983238 · Received April 1, 2022

    Report

    Report Number
    2210968-2022-02333
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    January 1, 2022
    Report Date
    June 1, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031062375
    PMA / PMN Number
    K132054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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, 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 MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. PHOTOS OF THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO FDA: 06/01/2022. 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. PHOTO ANALYSIS SUMMARY: NEUCHÂTEL TEAM RECEIVED FOR EVALUATION 2 PHOTOS OF ONE TVT EXACT DEVICE (PRODUCT CODE TVTRL), BATCH 3940326 WITH ONLY TWO WHITE PLASTIC NEEDLES, WITHOUT ANY PACKAGING PART OR TROCAR. IT CAN BE OBSERVED IN PHOTOS THAT THE DEVICE WAS OPENED AND MANIPULATED AS THERE WAS NO BOX, NO BLISTER, NO IFU AND NO TROCAR. IN PHOTOS ONLY THE 2 NEEDLES AND SMALL PARTS OF THE MESH ARE PRESENT. IT CAN BE ALSO OBSERVED IN THE PHOTO THAT ONE PART OF THE MESH IS DISCONNECTED OF THE NEEDLE. ADDITIONALLY, ORGANIC MATTER CAN BE SEEN ON THE DEVICE AND THE MESH HAS BEEN CUT. THE REPORTED EVENT "STRAP OF THE POKER TORE OFF" CAN BE OBSERVED IN PHOTOS AS THE MESH IS DISCONNECTED OF THE NEEDLE. HOWEVER, BASED IN THE PICTURES EVALUATION AND EVENT DESCRIPTION, THIS EVENT CANNOT BE DETERMINED TO BE A A MANUFACTURING ISSUE. NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED COMPLAINT, AS THE SAMPLE WAS NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE IN 2022 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT WHILE PULLING THE POKER THROUGH, THE STRAP OF THE POKER TORE OFF. IT WAS ALSO REPORTED THAT THEY WERE ALREADY FAR ENOUGH AND THEY COULD STILL USE IT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839253 TVT EXACT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. TVTRL 3940326 10705031062375

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown