BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYN DISPOSABLES TENACULUM 356T (COMPONENT OF GYN DISPOSABLES 935K IUD INSERTION

    MDR report key: 2766609 · Received September 21, 2012

    Report

    Report Number
    MW5027079
    Event Type
    Malfunction
    Date Received
    September 21, 2012
    Date of Event
    March 28, 2012
    Report Date
    September 12, 2012
    Manufacturer
    GYN DISPOSABLES
    Product Code
    OJV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSE PRACTITIONER SAYS THAT BOTH OF THE TENACULUM TIPS AND THE LOCKING RACHET BROKE DURING AN IUD PROCEDURE. SHE BELIEVED THE SIZE OF THE BROKEN TIPS WERE APPROXIMATELY 5MM FOR THE LEFT TIP AND 2 TO 3MM FOR THE RIGHT TIP. ONE TIP REMAINED LODGED IN PT; OTHER TIP WAS RETRIEVED. NURSE PRACTITIONER SAID THAT A LACERATION WAS IN BACK OF CERVIX FROM 4 O'CLOCK TO 8 O'CLOCK POSITION. PT HAD SLIGHT BLEEDING. PT LEFT, RESCHEDULED APPOINTMENT, CHECKED A WEEK LATER, AND EVERYTHING WAS FINE. NURSE PRACTITIONER SAID DATE OF OCCURRENCE WAS (B)(6) 2012. GYN DISPOSABLES WAS NOT INFORMED OF OCCURRENCE UNTIL (B)(6) 2012, DURING A SALES CALL. PRODUCT NOT AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYN DISPOSABLES TENACULUM 356T (COMPONENT OF GYN DISPOSABLES 935K IUD INSERTION TENACULUM OJV GYN DISPOSABLES NA 935K: 61172179

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK