BEUDAMED
    FDA Adverse Event Other Summary report: N

    VAGINAL APPLICATOR SET

    MDR report key: 117257 · Received August 4, 1997

    Report

    Report Number
    1121753-1997-00024
    Event Type
    Other
    Date Received
    August 4, 1997
    Date of Event
    April 15, 1997
    Manufacturer
    NUCLETRON BV
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    PT WAS RECEIVING FIRST VAGINAL CUFF BRACHYTHERAPY. DURING THE PROCEDURE THE END OF A VAGINAL TUBE PART NUMBER 084.002 AND THE 3.3 CM CYLINDER PART NUMBER 084.350 BECAME DETACHED DUE TO THE PLUG PART NUMBER 084.103 AT THE END OF THE TUBE BECOMING DETACHED FROM IT. AFTER COMPLETION OF THE TREATMENT, REMOVAL OF THE VAGINAL APPLICATOR WAS ATTEMPTED PULLING ON THE END OF THE VAGINAL TUBE. THE PLUG OF THE TUBE BECAME DETACHED. THE VAGINAL TUBE WAS REMOVED, LEAVING THE 3.5 CM CYLINDER SET AND PLUG END OF THE VAGINAL TUBE IN THE PT. THE PARTS WERE REMOVED BY VAGINAL EXAM WITH A TENACULUM. NO INJURY OR ADVERSE CONSEQUENCES WERE NOTED. THE METAL PLUG END OF THE VAGINAL TUBE WAS STILL ATTACHED TO THE CYLINDER SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAGINAL APPLICATOR SET NUCLETRON MICROSECOND HDR JAQ NUCLETRON BV VAGINAL APPLICATOR SET NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other