BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOUTH GAG MOLT CHILD

    MDR report key: 1386833 · Received May 8, 2009

    Report

    Report Number
    2411236-2009-00002
    Event Type
    Injury
    Date Received
    May 8, 2009
    Date of Event
    April 8, 2009
    Report Date
    April 8, 2009
    Manufacturer
    NOPA INSTRUMENTS
    Product Code
    KBN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DOCTOR WAS USING THE MOUTH GAG ON A (B) (6) FEMALE PATIENT WHEN THE RUBBER TIP CAME OFF AND ROLLED TO THE BACK OF THE PATIENT'S MOUTH. THE PATIENT WAS NOT HURT AND THE TIP WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOUTH GAG MOLT CHILD MOUTH GAG MOLT CHILD KBN NOPA INSTRUMENTS 0305P

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other