BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 192013 · Received October 15, 1998

    Report

    Report Number
    MW1014739
    Event Type
    Malfunction
    Date Received
    October 15, 1998
    Date of Event
    August 24, 1998
    Report Date
    September 25, 1998
    Manufacturer
    NUCLETRON OLDELFT CORP.
    Product Code
    IWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN FOR RADIATION ONCOLOGY PROCEDURE. TEMPLATE WAS IMPLANTED FOR INSTILLATION OF DUMMIES. DURING PROCEDURE A PORTION OF THE NEEDLE BROKE OFF AND BECAME LODGED IN THE PT'S CERVIX. PORTION OF INSTRUMENT RETAINED AND SENT TO MFR AT THEIR REQUEST FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant 20CM TROCHAR PATIENT NEEDLE IWF NUCLETRON OLDELFT CORP. 083.924 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other