BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 21676575 · Received March 24, 2025

    Report

    Report Number
    2210968-2025-03078
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    January 1, 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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ¿ WHERE WAS THE FOREIGN MATERIAL FOUND? (INSIDE SHIPPING BOX, INSIDE IMPLANT BOX, DIRECTLY ON DEVICE?) ¿ PLEASE DESCRIBE THE TYPE OF FOREIGN MATTER THAT WAS OBSERVED. ¿ ARE THERE ANY PHOTOS OF THE FOREIGN MATTER AVAILABLE? ¿ IS IT POSSIBLE THAT THE FOREIGN MATERIAL FELL INTO PACKAGING UPON OPENING OF DEVICE? ¿ WAS THE SEALS ON THE FOIL STILL INTACT WHEN THE PACKAGE WAS OPENED? ¿ WAS ANY HOLE, PUNCTURE, OR TEAR FOUND (KIT CARTON, PRE-FILLED SYRINGE PACKAGING, OR TIP PACKAGING) ¿ WHERE WAS THE HOLE, PUNCTURE, OR TEAR FOUND (KIT CARTON, PRE-FILLED SYRINGE PACKAGING, OR TIP PACKAGING). H3 ANALYSIS SUMMARY: (B)(6) TEAM RECEIVED FOR EVALUATION TWO PRODUCTS OF GYNECARE OBTURATOR PRODUCT CODE 810081 AND LOT NUMBER 3944731. AN INVESTIGATION WAS PERFORMED ON RECEIVED PRODUCT AND ON THE BATCH RECORD FILE. THE PRODUCT HAS BEEN DECONTAMINATED AND PROPERLY PACKAGED. THE RECEIVED DEVICE WAS OPENED AND MANIPULATED. IT WAS RETURNED: BOX OF FINAL PACKAGING WITH A GLUED LABEL THAT DOES NOT BELONG TO ETHICON NOR MANUFACTURING PROCESS, THE LABEL IDENTIFICATION STUCK CORRESPONDS TO LOT 3944731, SAME LOT AT THE COMPLAINT ORIGIN, THE BLISTER, THE IFU, WORKSTATION, TWO NEEDLES, TWO HANDLES, AN A4 SHEET WITH INFORMATION AND IS NOT FROM ETHICON, THE MESH WINGED GUIDE AND THE LID FROM PRIMARY PACKAGING. NO DAMAGES WERE FOUND IN THE LID, THE LABEL STUCK CORRESPONDS TO LOT 3944731, SAME LOT AT THE COMPLAINT ORIGIN. THE MARKS OF SEALING TRANSFER ARE VISIBLE ON LID, CONCLUDING THAT THE DEVICE PACKAGING WAS SEALED CORRECTLY. NO DAMAGE OR FOREIGN MATTER WERE DETECTED ON THE NEEDLES AND NEEDLE TIPS. ALL NEEDLE SURFACES ARE COMPLIANT. NO DAMAGES OR FOREIGN MATTER WERE DETECTED ON WINGED GUIDE. IT WAS OBSERVED PARTICLES OF BLUE MESH IN THE WORKSTATION. THE SIZES OF THE MESH PARTICLES WERE MEASURED WITH A TAPPI CHART (NE1636) AND A CALIBRATED RULER (G12463). ALL MEASURED PARTICLES WERE SMALLEST THAN 0.4MM2 OR 3MM IN LENGTH AND WERE SO ACCEPTABLE AND IN SPECIFICATIONS PER THE VISUAL STANDARD. THE PARTICLES COME FROM THE MESH (IMPLANT) MANUALLY CUT (CODE 810081) AND ARE NOT CONSIDERED AS FOREIGN MATTER. BASED TO THE EVALUATION, THIS COMPLAINT IS NOT RELATED TO A MANUFACTURING PROBLEM. THE PRODUCT WAS CONFORMING TO SPECIFICATIONS AT THE RELEASE. EVENTS OF THIS TYPE ARE TRENDED REGULARLY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE IN 2024 AND MESH WAS USED. PRE-OPERATIVELY, IT WAS NOTED THAT THE MESH WAS TEARING IN PRODUCT PART AND UNKNOWN SUBSTANCE IN PACKAGE, THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584477 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3944731 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown