BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGGA

    MDR report key: 16584134 · Received March 20, 2023

    Report

    Report Number
    MW5115878
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    June 21, 2019
    Report Date
    March 17, 2023
    Manufacturer
    ORTHOMATRIXCORP, INC
    Product Code
    JEP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD AN AGGA DENTAL APPLIANCE PUT IN ON (B)(6) 2019 WHICH MY BODY REJECTED ALMOST IMMEDIATELY. I HAD WHAT APPEARED TO BE SOME KIND OF EXTREME NERVOUS SYSTEM REACTION THAT MADE ME HAVE EXTREME ANXIETY ATTACKS, PAIN, AND DIFFICULTY BREATHING AND IT WORSENED MY SLEEP APNEA. I HAD TO HAVE AN EMERGENCY REMOVAL ON (B)(6) 2019 TO PREVENT ANY PERMANENT DAMAGE. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999324 AGGA RETAINER, MATRIX JEP ORTHOMATRIXCORP, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| O