BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 20230679 · Received September 16, 2024

    Report

    Report Number
    2210968-2024-09786
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    August 27, 2024
    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
    LO
    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. THE DEVICE UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE 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). 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. CORRECTED H3 ANALYSIS SUMMARY: NEUCHATEL TEAM RECEIVED FOR EVALUATION ONE GYNECARE OBTURATOR PRODUCT CODE 810081 AND LOT NUMBER 3944814. AN INVESTIGATION WAS PERFORMED ON RECEIVED PRODUCT AND ON THE BATCH RECORD FILE. THE PRODUCT HAS BEEN DECONTAMINATED AND PROPERLY PACKAGED. THE DEVICE RECEIVED WAS OPENED AND MANIPULATED THERE WAS NO BOX, NO BLISTER, NO IFU, NO COVER AND NO WING GUIDE. IT WAS RETURNED: TWO NEEDLES WITH PROLENE MESH AND THREE PIECES OF PROLENE MESH FROM ANOTHER TVT PRODUCT. NO DAMAGE OR FOREIGN BODIES WERE FOUND ON THE NEEDLES OR NEEDLE TIPS. IT WAS OBSERVED THAT, THE MESH HAS BEEN STRETCHED WHICH CAUSES SOME DAMAGE ON THE BORDERS RELEASE OF SOME SMALL MESH PARTICLES. BASED TO THE EVALUATION, THIS COMPLAINT IS NOT RELATED TO A MANUFACTURING PROBLEM. THE DEFECT OBSERVED DURING THE EVALUATION CORRESPONDS TO THE DESCRIPTION OF THE EVENT, BUT IT IS NOT RELATED TO MANUFACTURING. THE PRODUCT WAS CONFORMING TO SPECIFICATIONS AT THE RELEASE. EVENTS OF THIS TYPE ARE TRENDED REGULARLY.

    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 RESPONSE WAS OBTAINED: - WHAT QUALITY ISSUE WAS EXPERIENCED WITH THE PRODUCT? THE TAPE IS TEARING APART - IS THE QUALITY ISSUE SPECIFIC TO THE DEVICE OR PATIENT CONSEQUENCE? PRODUCT ISSUE - 1 PIECE FROM EACH LOT WERE USED/OPENED AND TORN APART. - WAS THERE ANY PATIENT CONSEQUENCE? NO ATTEMPTS ARE BEING MADE TO RETRIEVE THE DEVICE. 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED 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. H3 ANALYSIS SUMMARY: NEUCHATEL TEAM RECEIVED FOR EVALUATION THREE PHOTOS OF ONE GYNECARE OBTURATOR PRODUCT CODE 810081 AND LOT NUMBER 3944814. AN INVESTIGATION WAS PERFORMED ON RECEIVED PRODUCT AND ON THE BATCH RECORD FILE. THE PRODUCT HAS BEEN DECONTAMINATED AND PROPERLY PACKAGED. THE DEVICE RECEIVED WAS OPENED AND MANIPULATED THERE WAS NO BOX, NO BLISTER, NO IFU, NO COVER AND NO WING GUIDE. IT WAS RETURNED: TWO NEEDLES WITH PROLENE MESH AND THREE PIECES OF PROLENE MESH FROM ANOTHER TVT PRODUCT. NO DAMAGE OR FOREIGN BODIES WERE FOUND ON THE NEEDLES OR NEEDLE TIPS. IT WAS OBSERVED THAT, THE MESH HAS BEEN STRETCHED WHICH CAUSES SOME DAMAGE ON THE BORDERS RELEASE OF SOME SMALL MESH PARTICLES. BASED TO THE EVALUATION, THIS COMPLAINT IS NOT RELATED TO A MANUFACTURING PROBLEM. THE DEFECT OBSERVED DURING THE EVALUATION CORRESPONDS TO THE DESCRIPTION OF THE EVENT, BUT IT IS NOT RELATED TO MANUFACTURING. 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 AN UNSPECIFIED PROCEDURE ON (B)(6) 2024 AND MESH WAS USED. THE PRODUCT HAS NOT THE NORMAL QUALITY AND THE TAPE WAS TEARING APART. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2527706 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3944814 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown