BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOUTH GAG MOLT CHILD

    MDR report key: 1250503 · Received December 3, 2008

    Report

    Report Number
    2411236-2008-25840
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 5, 2008
    Manufacturer
    NOPA INSTRUMENTS
    Product Code
    KBN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTIST WAS WORKING ON A SPECIAL NEEDS PT, WHO NEEDS THE MOUTH GAG TO HOLD OPEN HIS MOUTH. THE PT MOVED AND PUSHED THE GAG OUT OF HIS MOUTH CAUSING THE TIP TO COME OFF THE INSTRUMENT. THE PT SWALLOWED THE TIP BEFORE THE DENTIST COULD RETRIEVE IT FROM HIS MOUTH. NINE ELEVEN WAS CALLED BUT IT WAS DETERMINED THAT HIS BREATHING WAS FINE AND HE NEEDS NO MEDICAL ATTN. THE PT PASSED THE TIP TWO DAYS LATER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other