BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGGA DENTAL DEVICE

    MDR report key: 16714294 · Received April 10, 2023

    Report

    Report Number
    MW5116516
    Event Type
    Injury
    Date Received
    April 10, 2023
    Date of Event
    March 13, 2023
    Report Date
    April 6, 2023
    Manufacturer
    UNK
    Product Code
    JEP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS FIT FOR AN AGGA APPLIANCE BY MY DENTIST. I ONLY HAD THE BOTTOM PLACED FIRST FOR ABOUT A WEEK, THEN THE TOP. I HAD INTENSE PAIN, GUM IRRITATION, MIGRAINES, AND STARTED FINALLY SPITTING UP BLOOD AT RANDOM TIMES. THIS WAS BRIGHT RED BLOOD LEAKING OUT OF MY GUMS AT RANDOM TIMES. ALL OF A SUDDEN I COULD FEEL A WARM SENSATION AND WOULD SPIT BRIGHT RED BLOOD MULTIPLE TIMES PER DAY. I FINALLY DEMANDED THE DEVICE BE REMOVED FROM MY TEETH. I STILL HAVE CEMENT ALL OVER MY TEETH AFTER GETTING IT OFF OVER 3 WEEKS AGO AND PAIN IN MY RIGHT SIDE MOUTH TOP TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1852566 AGGA DENTAL DEVICE RETAINER, MATRIX JEP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Other| R ADDERALL| CURRENTLY USING A PRE FABRICATED GUARD IN MY MOUTH| EFFEXOR| NAPROXEN | TYLENOL