BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 11216943 · Received January 22, 2021

    Report

    Report Number
    2210968-2021-00597
    Event Type
    Malfunction
    Date Received
    January 22, 2021
    Date of Event
    January 14, 2020
    Report Date
    January 15, 2021
    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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS SUMMARY: RECEIVED FOR EVALUATION WERE SOME PARTS OF A GYNECARE TVT OBTURATOR PRODUCT CODE 810081, BATCH: 3935633. THE RECEIVED DEVICE WAS MANIPULATED. THE IMPLANT WAS RETURNED WITH THE LID, WHITE PLASTIC NEEDLES, HELICAL PASSERS, WINGED GUIDE AND MESH. ORGANIC MATTER WAS VISIBLE ON THE DIFFERENT COMPONENTS. ONE OF THE HELICAL PASSER WAS DISASSEMBLED FROM ITS PLASTIC NEEDLE AND THIS NEEDLE WAS TORN OFF. THE DEFECT IDENTIFIED IS NOT LINKED TO A MANUFACTURING ISSUE AND THE POTENTIAL CAUSE IS EXTERNAL CAUSE (USER USED). THE PRODUCT WAS CONFORMING TO SPECIFICATIONS AT THE RELEASE. THE MANUFACTURING PROCESS COULD NOT CREATE THIS DEFECT. THE MESH WAS IN GOOD CONDITION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH, AND NO NON-CONFORMANCES WERE IDENTIFIED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE MESH PRODUCT WAS FOUND TO BE DEFECTIVE AND THE PRODUCT WAS USED NOT SMOOTHLY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111906 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 810081 3935633 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1