BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYN DISPOSABLE TENACULUM 356T

    MDR report key: 1474821 · Received June 22, 2009

    Report

    Report Number
    3006365741-2009-00001
    Event Type
    Malfunction
    Date Received
    June 22, 2009
    Date of Event
    May 11, 2009
    Report Date
    June 22, 2009
    Manufacturer
    GYN-DISPOSABLES
    Product Code
    HDC
    PMA / PMN Number
    K073182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    NURSE PRACTITIONER SAYS THAT ONE OF THE TENACULUM TIPS BROKE WHILE SHE WAS REMOVING THE TENACULUM FROM THE CERVIX (AFTER AN IUD INSERTION PROCEDURE). SHE TRIED TO FIND THE BROKEN PIECE AND WAS UNSUCCESSFUL. THERE WAS NO FURTHER INTERVENTION REQUIRED. THE TIP PROTECTOR WAS IN PLACE WHEN PACKAGE WAS OPENED. THE NURSE PRACTITIONER DISPOSED OF THE TENACULUM SO IT CANNOT BE RETURNED FOR EVAL. NURSE PRACTITIONER DID NOT NOTIFY MFR AT THE TIME OF THE OCCURRENCE AS SHE DID NOT FEEL THAT THIS OCCURRENCE WAS A BIG CONCERN. THE INCIDENT WAS DISCOVERED ON (B)(6) 2009 WHEN MFR MADE A SALES FOLLOW-UP TELEPHONE CALL. ON 06/22/2009, MFR MADE A FOLLOW-UP TELEPHONE CALL TO THE NURSE PRACTITIONER WHO SAID THAT THERE WERE NO COMPLICATIONS WITH THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYN DISPOSABLE TENACULUM 356T TENACULUM HDC GYN-DISPOSABLES 935K 60134034

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other INSERTION PROCEDURE.| EVENT OCCURRED AFTER COMPLETION OF AN IUD