BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COHEN INTRAUTERINE PROBE

    MDR report key: 658736 · Received January 4, 2006

    Report

    Report Number
    2430952-2006-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2006
    Report Date
    January 4, 2006
    Manufacturer
    TROKAMED GMBH
    Product Code
    ---
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE FAMILY MEMBER OF THE PT CONTACTED THE USER FACILITY SEVERAL MONTHS FOLLOWING THE PT'S SURGICAL PROCEDURE STATING THAT HIS DAUGHTER HAD A FOUL SMELLING VAGINAL ODOR THAT CAUSED THEM TO SEEK MEDICAL TREATMENT. IT WAS DISCOVERED THAT THE TIP OF THE INTRAUTERINE PROBE WAS STILL INSIDE THE PT. THE TIP HAS BEEN REMOVED AND THE PT HAS RECOVERED. USER FACILITY STATED THAT THE TIP OF THE PROBE HAD A REMOVABLE PIECE THAT TWISTED INTO THE PROBE AND WAS EASILY DISCONNECTED. THE USER FACILITY WAS CONTACTED AFTER RECEIVING THE COPY OF MEDWATCH. THE TIP WAS NOT AVAILABLE FOR EVALUATION BECAUSE THE HOSP HAD A NUMBER OF INSTRUMENTS AND THEY WERE NOT ABLE TO IDENTIFY WHICH INSTRUMENT WAS USED DURING THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COHEN INTRAUTERINE PROBE JARIT ENDOSCOPIC INSTRUMENTS --- TROKAMED GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *