BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPE PROMPT L-POP (DENTAL)

    MDR report key: 387074 · Received April 4, 2002

    Report

    Report Number
    MW1024596
    Event Type
    Malfunction
    Date Received
    April 4, 2002
    Date of Event
    March 14, 2002
    Report Date
    March 25, 2002
    Manufacturer
    3-M
    Product Code
    DYH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DENTAL HYGIENIST WAS PREPARING #18 TOOTH (LOWER RIGHT 2ND MOLAR) TO PLACE A SCULANT. A "3-M" ESPE PROMPT L-POP WAS USED TO ETCH THE TOOTH. THEY NOTICED A BURN ON THE MUCOSA OF THE RIGHT CHEEK OPPOSITE TO #18. THERE WAS NO PAIN AT THE TIME. RINSED AND INFORMED THE PT AND THEIR FAMILY MEMBER. FOLLOWED UP WITH A PHONE CALL TO CHECK ON PT. NO PROBLEM REPORTED. THE BURN WAS A WHITE LESION ABOUT 4 MM X 20 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPE PROMPT L-POP (DENTAL) ETCH/ADHESIVE FOR COMPOSIT FILLING DYH 3-M * 107536

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other