BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMA

    MDR report key: 18088216 · Received November 7, 2023

    Report

    Report Number
    3004588608-2023-00005
    Event Type
    Injury
    Date Received
    November 7, 2023
    Report Date
    October 9, 2023
    Manufacturer
    THE MYERSON COMPANY LIMITED
    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 · 0

    THE FOLLOWING INFORMATION WAS NOT PROVIDED BY THE CUSTOMER: A2: PATIENT AGE AND DATE OF BIRTH A3: PATIENT SEX A4: PATIENT WEIGHT A5: PATIENT ETHNICITY A6: PATIENT RACE B2: THIS HARM WAS NOT CONSIDERED TO BE AN ADVERSE EVENT SINCE THE INCIDENT DID NOT RESULT IN DEATH OR SERIOUS INJURY AND DOES NOT HAVE THE LIKELIHOOD TO RESULT IN DEATH OR SERIOUS INJURY TO THE PATIENT. THIS IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION AND AS PER GUIDANCE BY AN FDA INSPECTOR WHO ADVISED THAT THE FDA MIGHT BE INTERESTED IN THE DATA FOR TRENDING PURPOSES. B3: THE DATE OF THE EVENT WAS UNKNOWN TO THE CUSTOMER. D4: THE DEVICE COMPRISES OF 4 SETS OF COMPONENTS. THE LOT # FOR THE 4TH ITEM, THE STRAPS, IS # S061622 THE EXPIRY DATES ARE AS FOLLOWS: DISKS: 2023-11-29 BUTTONS: 2025-09-23 BITE PADS: 2025-05-30 STRAPS:2025-06-16 H4: THE DATE THAT THE CUSTOM FIT DEVICE WAS MADE IS UNKNOWN. NO INFORMATION WAS PROVIDED BY THE DENTAL LABORATORY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO THE EMA THAT WAS ISSUED. IT IS UNCLEAR WHEN THE PATIENT RECEIVED THE DEVICE. THE PATIENT REPORTED THAT HIS/HER LIPS HAD SWOLLEN AROUND THE BUCCAL MUCOUS. PRIOR TO THIS INCIDENT, IT WAS NOTED THAT THE PATIENT'S TONGUE AND THROAT SWELLED UP. THE SYMPTOMS WENT AWAY AT THE END OF THE DAY OR A DAY AND A HALF AFTER TAKING BENADRYL. THE PATIENT DISCONTINUED USE OF THE DEVICE. THE PATIENT HAS NO KNOWN ALLERGIES BUT WILL GET AN ALLERGY TEST FROM THEIR MEDICAL PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276580 EMA SLEEP DEVICE LRK THE MYERSON COMPANY LIMITED EMATD12010, EMABN2, EMABP,EMAST21YM TD11736,BN2B092322,BP053022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown