BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSONIC ULTRASONIC SCALER

    MDR report key: 356021 · Received October 10, 2001

    Report

    Report Number
    2416455-2001-00001
    Event Type
    Malfunction
    Date Received
    October 10, 2001
    Date of Event
    August 16, 2001
    Report Date
    October 10, 2001
    Manufacturer
    COLTENE/WHALEDENT INC.
    Product Code
    ELC
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING AN ULTRASONIC SCALING PROCEDURE, THE SCALER INSERT EJECTED FROM THE HAND PIECE. THE MATTER WAS REFERRED TO THE RESPECTIVE PRODUCT MGR WHO CONTACTED THE DRS OFFICE AND WAS INFORMED THAT THE DEVICE WAS NOT BEING USED, THAT IT WAS PACKED UP WAITING TO BE RETURNED TO C/W FOR INVESTIGATION. THE CALLER WAS ADVISED THAT C/W WOULD ISSUE A CALL TAG. ON 09/2001, IN ANOTHER TELEPHONE CALL, SALES REP ADVISED VERBALLY THAT THERE WAS PT INJURY - THIS IS THE FIRST TIME THAT PT INJURY WAS MENTIONED. 9/2001: CO REP OF C/W SPOKE TO ASSISTANT AT DR.'S OFFICE, TO ASCERTAIN SOME MORE DETAILS. DR WAS BUSY AND UNABLE TO TALK. ASSISTANT WAS VERY DIFFICULT TO UNDERSTAND DUE TO ASSISTANT'S ACCENT. ASSISTANT CONFIRMED THAT THERE WERE INDEED TWO INCIDENTS. IT APPEARS THAT UPON EJECTION OF THE INSERT FROM THE HANDPIECE, THE SCALER TIP INJURED THE PALATE OF THESE TWO PTS. PT 1 - ON EVENT DATE: THE PT WAS IN GENERAL GOOD HEALTH. DURING A SCALING PROCEDURE, THE INSERT EJECTED AND INJURED THE PALATE. PT WAS GIVEN XILOXIN AND A RX FOR ADDITIONAL MEDICATION AND SENT HOME. PT 2 - THE NEXT DAY: PT IN GENERAL GOOD HEALTH HAD A VERY SIMILAR OCCURRENCE AND OUTCOME WAS SAME, SMALL INJURY. THE ASSISTANT SAID THAT, AS OF 09/2001, BOTH PTS ARE FINE WITHOUT ANY UNTOWARD EFFECTS.

    Description of Event or Problem · 2

    WHILE PERFORMING AN ULTRASONIC SCALING PROCEDURE, THE SCALER INSERT EJECTED FROM THE HAND PIECE. THE MATTER WAS REFERRED TO THE RESPECTIVE PRODUCT MGR WHO CONTACTED THE DR'S OFFICE AND WAS INFORMED THAT THE DEVICE WAS NOT BEING USED, THAT IT WAS PACKED UP WAITING TO BE RETURNED TO C/W FOR INVESTIGATION. THE CALLER WAS ADVISED THAT C/W WOULD ISSUE A CALL TAG. ON 09/2001, IN ANOTHER TELEPHONE CALL, SALES REP ADVISED VERBALLY THAT THERE WAS PT INJURY - THIS IS THE FIRST TIME THAT PT INJURY WAS MENTIONED. 09/2001: CO REP OF C/W SPOKE TO ASSISTANT AT DR'S OFFICE, TO ASCERTAIN SOME MORE DETAILS. DR WAS BUSY AND UNABLE TO TALK. ASSISTANT WAS VERY DIFFICULT TO UNDERSTAND DUE TO ASSISTANT'S ACCENT. ASSISTANT CONFIRMED THAT THERE WERE INDEED TWO INCIDENTS. IT APPEARS THAT UPON EJECTION OF THE INSERT FROM THE HANDPIECE, THE SCALER TIP INJURED THE PALATE OF THESE TWO PTS. PT 1 - ON EVENT DATE: THE PT WAS IN GENERAL GOOD HEALTH. DURING A SCALING PROCEDURE, THE INSERT EJECTED AND INJURED THE PALATE. PT WAS GIVEN XILOXIN AND A RX FOR ADD'L MEDICATION AND SENT HOME. PATIENT 2 - THE NEXT DAY: PT IN GENERAL GOOD HEALTH HAD A VERY SIMILAR OCCURRENCE AND OUTCOME WAS SAME, SMALL INJURY. ASSISTANT SAID THAT, AS OF 09/2001, BOTH PATIENTS ARE FINE WITHOUT ANY UNTOWARD EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45549 BIOSONIC ULTRASONIC SCALER ULTRASONIC SCALER ELC COLTENE/WHALEDENT INC. US100-115 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other
    2 40 YR Other