BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSOMNUS [IA] SLEEP AND SNORE DEVICE

    MDR report key: 14682758 · Received June 14, 2022

    Report

    Report Number
    3013116677-2022-00002
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    May 5, 2022
    Report Date
    June 14, 2022
    Manufacturer
    PROSOMNUS SLEEP TECHNOLOGIES
    Product Code
    LRK
    UDI-DI
    00863039000416
    PMA / PMN Number
    K172859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SCAN SENT BY THE DOCTOR TO PROSOMNUS SEEMED TO BE DISTORED AS THE DEVICE WAS DESIGNED AROUND THE FILES RECEIVED. THE FINISHED DEVICE PASSED THE PROSOMNUS QUALITY STANDARD AT FINAL QUALITY CONTROL. THE DOCTOR ALSO MENTIONED THAT THEY EXTENSIVELY GROUND THE ARCH TO TRY MAKING IT FIT WHICH IS ANOTHER INDICATION THAT THE RECORDS RECEIVED WERE NOT ACCURATE. THE DEVICE BROKE DURING THE ADJUSTMENT DUE TO THE EXTENT OF THE DISTORTION. THE PATIENT HAD A CROWN MADE TO REPLACE THE CHIPPED TOOTH AND A NEW DEVICE HAS BEEN MADE ON THE NEW SCAN RECEIVED.

    Description of Event or Problem · 0

    PATIENT'S TOOTH #7 CHIPPED OFF DURING HER DELIVERY APPOINTMENT . THE DOCTOR REPORTED THAT SHE TRIED TO ADJUST THE TRAY, BUT IT BROKE IN HALF IN THE #7 AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181916 PROSOMNUS [IA] SLEEP AND SNORE DEVICE MICRO2 OBSTRUCTIVE SLEEP APNEA DEVICE LRK PROSOMNUS SLEEP TECHNOLOGIES 1309 00863039000416

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention