BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSOMNUS EVO SLEEP AND SNORE DEVICE

    MDR report key: 17741540 · Received September 13, 2023

    Report

    Report Number
    3013116677-2023-00001
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    February 8, 2022
    Report Date
    September 13, 2023
    Manufacturer
    PROSOMNUS SLEEP TECHNOLOGIES
    Product Code
    LRK
    UDI-DI
    00863039000492
    PMA / PMN Number
    K202529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PROSOMNUS MANDIBULAR ADVANCEMENT DEVICE INDICATIONS FOR USE DOES NOT INDICATE TO USE THE DEVICE WITH SUPPLEMENTAL OXYGEN. THE PATIENT MUST FOLLOW HIS/HER PRESCRIBER'S ADVICE OR ORDER. THE PATIENT ALSO SELF TESTED SLEEP APNEA EPISODES USING A PULSE OXIMETER PURCHASED FROM EBAY. PATIENT REPORTED LOSING 20 LBS OF BODY WEIGHT AND THE PROSOMNUS DEVICE IS NOT INTENDED TO LOSE WEIGHT OR CURE OBSTRUCTIVE SLEEP APNEA. PROSOMNUS SLEEP DEVICES ARE USED TO ALLEVIATE OBSTRUCTIVE SLEEP APNEA AND SNORING AS THE INDICATIONS STATE. ELIMINATING THE USE OF OXYGEN MUST ONLY BE DONE UNDER MEDICAL ADVICE OR SUPERVISION. THE PATIENT'S SERIOUS ALLEGATIONS HAS LITTLE OR NO PROOF TO THE ADVERSE EVENTS CAUSED. THE PATIENT ALSO REPORTED TO FDA ABOUT THE USE OF PROSOMNUS DEVICE WITH PATIENT MONITORING. AFTER INVESTIGATING FURTHER, THE DEVICE PRESCRIBED BY THE PATIENT'S DENTIST DID NOT HAVE A PATIENT MONITORING SENSOR EMBEDDED IN THE DEVICE. THERE WAS ONLY ONE PRECRIPTION FROM THE PATIENT'S DENTIST AND ONLY ONE SET OF DEVICE WAS MANUFACTURERED FOR THE PATIENT, AND PROSOMNUS DID NOT GET A SECOND PRESCRITION FOR THIS PATIENT. PATIENT'S PRESCRIBER WAS CONTACTED AND PATIENT HAD STATED THE DEVICE WAS PERFORMING VERY WELL, LOSING WEIGHT, FEELING HEALTHY, AND BETTER SLEEP. THE DEVICE DID NOT FAIL TO PERFORM AS EXPECTED. PROSOMNUS STRIVES FOR EXCELLENCE AND TO PROVIDE SAFE AND EFFECTIVE DEVICES. THERE IS ENOUGH CLINICAL EVIDENCE IN ALLEVIATING OBSTRUCTIVE SLEEP APNEA FROM USING PROSOMNUS DEVICES. SERVICE AND QUALITY IS OUR PRIORITY.

    Description of Event or Problem · 0

    PROSOMNUS SLEEP TECHNOLOGIES IS THE MANUFACTURER OF MANDIBULAR ADVANCEMENT DEVICES FOR THE TREATMENT OF OBSTRUCTIVE SLEEP APNEA AND SNORING. THE PATIENT REPORTED TO FDA ABOUT PROSOMNUS DEVICE IS SUSPECTED TO HAVE AN ADVERSE OUTCOME. FDA FORWARDED THE REPORT TO PROSOMNUS ON 08/24/2023. THE PATIENT REPORTED SLEEP DYSFUNCTION AND WEIGHT CHANGES FROM USING PROSOMNUS DEVICE. THE PATIENT REPORTED MONITORING SLEEP APNEA EPISODES USING A PULSE OXIMETER PURCHASED FROM EBAY. PATIENT ALSO REPORTED LOSING 20 LBS OF BODY WEIGHT AND THE DEVICE IS NOT INTENDED TO LOSE WEIGHT OR CURE OBSTRUCTIVE SLEEP APNEA. PROSOMNUS SLEEP DEVICES ARE USED TO ALLEVIATE OBSTRUCTIVE SLEEP APNEA AND SNORING AS THE INDICATIONS STATE. ELIMINATING THE USE OF SUPPLEMENTAL OXYGEN MUST ONLY BE DONE UNDER MEDICAL ADVICE OR SUPERVISION. THE PATIENT'S SERIOUS ALLEGATIONS HAS LITTLE OR NO PROOF AS THERE IS ENOUGH CLINICAL EVIDENCE IN ALLEVIATING OBSTRUCTIVE SLEEP APNEA FROM USING PROSOMNUS DEVICES. THE PATIENT ALSO REPORTED TO FDA ABOUT THE USE OF PROSOMNUS DEVICE WITH PATIENT MONITORING. AFTER INVESTIGATING FURTHER, THE DEVICE PRESCRIBED BY THE PATIENT'S DENTIST DID NOT HAVE A PATIENT MONITORING SENSOR EMBEDDED IN THE DEVICE. THERE WAS ONLY ONE PRECRIPTION FROM THE PATIENT'S DENTIST AND ONLY ONE SET OF DEVICE WAS MANUFACTURERED FOR THE PATIENT, AND PROSOMNUS DID NOT GET A SECOND PRESCRIPTION FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2282805 PROSOMNUS EVO SLEEP AND SNORE DEVICE PROSOMNUS EVO SLEEP AND SNORE DEVICE LRK PROSOMNUS SLEEP TECHNOLOGIES 1450 00863039000492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other ASPIRIN| ATENOLOL| ATORVASTATIN| DULOXETINE| EUTHYROX| HCTZ| OVER THE COUNTER PULSE OXIMETER| OZEMPIC INJECTIONS| POT CL MICRO TAB| SUPPLEMENTAL OXYGEN DURING SLEEP