BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 366236 · Received December 14, 2001

    Report

    Report Number
    MW1023618
    Event Type
    Malfunction
    Date Received
    December 14, 2001
    Date of Event
    December 12, 2001
    Report Date
    December 14, 2001
    Manufacturer
    SAGE PRODUCTS INC
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    SPONGE PIECE CAME OFF THE HANDLE IN THE PT'S MOUTH WHILE BEING USED ON TEETH AND GUMS. SPONGE PIECE WAS RETRIEVED BY THE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56599 * ORAL SUCTION BRUSH JOL SAGE PRODUCTS INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR