BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSOMNUS [IA] SLEEP AND SNORE DEVICE

    MDR report key: 10589316 · Received September 25, 2020

    Report

    Report Number
    3013116677-2020-00001
    Event Type
    Injury
    Date Received
    September 25, 2020
    Date of Event
    August 27, 2020
    Report Date
    September 25, 2020
    Manufacturer
    PROSOMNUS SLEEP TECHNOLOGIES
    Product Code
    LRK
    UDI-DI
    00863039000416
    PMA / PMN Number
    K133683
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTIST REPORTED THAT THE PATIENT BROKE TOOTH #14, WHICH HAD A TWO SURFACE COMPOSITE IN IT WHILE WEARING THE DEVICE. THE CROWN WAS CEMENTED AND THE DENTIST TEMPORARILY ADJUSTED THE DEVICE AND REPORTED THAT IT WORKED FAIRLY WELL. HOWEVER, THE PATIENT BROKE TEETH #5 AND #23 SOON AFTER. UPON FURTHER QUESTIONING, THE DENTIST REPORTED THAT THE CROWN WAS CEMENTED AND ANOTHER ORAL DEVICE WAS MADE FOR THE PATIENT. THE PATIENT DID NOT NEED ANY MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054633 PROSOMNUS [IA] SLEEP AND SNORE DEVICE MICRO2 OBSTRUCTIVE SLEEP APNEA DEVICE LRK PROSOMNUS SLEEP TECHNOLOGIES IA Monogram 00863039000416

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention