BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 19634462 · Received June 28, 2024

    Report

    Report Number
    2210968-2024-06763
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    April 23, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031000346
    PMA / PMN Number
    K033568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    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. H3 ANALYSIS SUMMARY: NEUCHATEL TEAM RECEIVED FOR EVALUATION ONE 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 BECAUSE THERE WAS NO BOX, NO BLISTER AND NO IFU. IT WAS RETURNED: TWO NEEDLES, TWO HANDLES , 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 DAMAGES OR FOREIGN MATTER WERE DETECTED ON WINGED GUIDE. THE NEEDLES WERE RECEIVED WITH TAPE AROUND THE TIP. THE TAPE WAS REMOVED DURING THE EVALUATION AND NO DAMAGES WERE FOUND IN NEEDLE TIPS. ALL NEEDLE SURFACES ARE COMPLIANT. THE MESH HAS BEEN STRETCHED AND HAS SOME DAMAGE ON THE BORDERS WHICH CAUSES THE RELEASE OF SMALL MESH PARTICLES. 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 PRODUCT WAS CONFORMING TO SPECIFICATIONS AT THE RELEASE. EVENTS OF THIS TYPE ARE TRENDED REGULARLY. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A URINARY INCONTINENCE SURGERY ON (B)(6) 2024 AND MESH WAS USED. PRE-OPERATIVELY, THE DOCTOR OPENED THE PACKAGING AND FOUND THAT ONE PART OF THE SLING WAS BROKEN. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786996 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3944731 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown