BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAR

    MDR report key: 22854 · Received September 1, 1994

    Report

    Report Number
    2411236-1993-00242
    Event Type
    Malfunction
    Date Received
    September 1, 1994
    Date of Event
    November 5, 1993
    Report Date
    November 9, 1993
    Manufacturer
    STAR DENTAL
    Product Code
    JEW
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Description of Event or Problem · 1

    REGISTERED HYGENIST WAS DOING ROUTINE PROPHY ON UPPER RIGHT QUADRANT WHEN APPROXIMATELY 4MM OF SCALER TIP BROKE OFF INPT'S MOUTH AND WAS EVACUATED BY ASPIRATOR. PT WAS NOT INJURED. TIP HAD BEEN WORKING NORMALLY UP TO THE MOMENT IT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAR TITANS PERIO TIP JEW STAR DENTAL #61669

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other