BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMA

    MDR report key: 12582826 · Received October 6, 2021

    Report

    Report Number
    3004588608-2021-00002
    Event Type
    Injury
    Date Received
    October 6, 2021
    Report Date
    September 10, 2021
    Product Code
    LRK
    PMA / PMN Number
    K971794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE EMA DEVICE IS MADE UP OF 4 COMPONENTS FROM THE MYERSON COMPANY LIMITED AND A BONDING AGENT FROM THE DENTAL LABORATORY WHICH COMBINES THE COMPONENTS TO MAKE A CUSTOM- FIT DEVICE FOR THE PATIENT. ALL OF THE LOT#S COULD NOT FIT IN SO THEY ARE BEING LISTED HERE: DISCS- TD051021; BUTTONS - BN2B032521; BITE PADS - BPB032921; YELLOW SIZE 21 STRAPS - S041021; BONDING AGENT - UNKNOWN, NOT PROVIDED BY THE CUSTOMER. MYERSON HAS DONE BIOCOMPATIBILITY TESTING IN THE PAST AND HAVE CONFIRMED THAT ITS MATERIAL ARE SAFE TO USE. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THESE LOTS. NO CHANGES HAVE BEEN MADE TO THE MANUFACTURING STEPS. THE CAUSE OF ALLERGIC REACTION IS INCONCLUSIVE AT THIS TIME. POTENTIAL CAUSES IDENTIFIED IN THE PAST INCLUDED EXTERNAL SOURCES SUCH AS A PATIENT'S MEDICATION, AND SOAKING OF THE APPLIANCE IN MOUTHWASH. AN ALLERGY TEST HAS BEEN REQUESTED AND MYERSON IS NOW AWAITING FEEDBACK FROM THE CUSTOMER. THIS REPORT WILL BE UPDATED IF MEANINGFUL FEEDBACK IS RECEIVED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR, (B)(4), RECEIVED A REPORT THAT A PATIENT HAD A REACTION TO HIS / HER EMA DEVICE. IT WAS REPORTED THAT THE APPLIANCE WAS WORN FOR A FEW MINUTES; THEN IT WAS REMOVED. NO REACTION WAS REPORTED TO THE DENTIST. THEN NEXT NIGHT, THE PATIENT WORE THE DEVICE AGAIN. NO DATE WAS PROVIDED. THE FOLLOWING REACTION OCCURRED: THE GUMS WERE RED AND SWOLLEN WITH THE LIPS TINGLING. THE REACTION LASTED 16 HOURS AFTER THE DISCONTINUATION OF USE OF THE DEVICE. THE PATIENT HAS A KNOWN ALLERGY TO SULFA. THE PATIENT WAS ADVISED TO HAVE AN ALLERGY TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483088 EMA ELASTIC MANDIBULAR ADVANCEMENT APPLIANCE LRK EMATD12010,EMABN2,EMABP,EMAST21YM NOT ENOUGH ROOM FOR THIS DATA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR