BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCLEAN PROPHYLAXIS PASTE

    MDR report key: 9295702 · Received November 7, 2019

    Report

    Report Number
    MW5090984
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Report Date
    November 3, 2019
    Manufacturer
    UNK
    Product Code
    EJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE SINGLE UNIT DOSE CUPS HAD HOLES OR PERFORATIONS IN THE TOPS OF ALL. THE UNITS IN THE BOX, THUS MAKING THEM OPEN AND NONSTERILE. HENRY SCHEIN, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088517 ACCLEAN PROPHYLAXIS PASTE AGENT, POLISHING ABRASIVE, ORAL CAVITY EJR UNK 0730191
    1088518 ACCLEAN PROPHYLAXIS PASTE AGENT, POLISHING ABRASIVE, ORAL CAVITY EJR UNK 051519P

    Patients

    Seq Age Sex Outcome Treatment
    1