BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSOMNUS SLEEP AND SNORE DEVICE

    MDR report key: 21862458 · Received April 17, 2025

    Report

    Report Number
    3013116677-2025-00002
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    February 20, 2025
    Report Date
    April 17, 2025
    Manufacturer
    PROSOMNUS SLEEP TECHNOLOGIES
    Product Code
    LRK
    PMA / PMN Number
    K202529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE INITIAL REPORTER REQUESTED TO THE FDA/CDRH TO REMAIN ANONYMOUS/CONFIDENTIAL, THIS LIMITED THE GATHERING OF INFORMATION TO CONDUCT A MORE THOROUGH INVESTIGATION. THE INITIAL REPORTER COULD NOT BE CONTACTED AS NO CONTACT INFORMATION WAS MADE AVAILABLE. THE MANUFACTURER CANNOT LOOK INTO DEVICE HISTORY RECORDS (DHR) WITHOUT A DEVICE IDENTIFIER FOR THE PROSOMNUS SLEEP AND SNORE DEVICE. PROSOMNUS SLEEP TECHNOLOGIES TAKES THIS ALLEGED DEVICE MALFUNCTION SERIOUSLY AND THE DEVICE RELATED RISK MANAGEMENT FILES CONTAIN A MITIGATION STRATEGY FOR THIS TYPE OF EVENT. PROSOMNUS HAS CONSIDERED AND MITIGATED HAZARDOUS SITUATIONS SUCH AS LOOSE FRAGMENT FROM DEVICE BREAKAGE THAT COULD RESULT IN CHOKING HAZARD OR LEAD TO ASPIRATION, SWALLOWING, OR LODGING. ALSO, THE INITIAL REPORTER'S USE OF THE TERM "CLIP" LEADS US TO THINK OF TWO PARTS ON THE DEVICE, WHICH COULD BE EITHER THE POST OR THE METAL FREE HOOK. HOWEVER THERE IS NO "CLIP" ON THE DEVICE. THERE ARE OTHER FACTORS THAT LEAD TO INSUFFICIENT INFORMATION TO FORMALIZE A THOROUGH INVESTIGATION; WE DO NOT KNOW THE CONDITION OF USE OR THE LENGTH OF USE OF THE DEVICE, WE DO NOT KNOW IF THE DEVICE WAS ALTERED OR DAMAGED BY PATIENT, PRESCRIBER, OR ANOTHER PARTY. DUE TO THE LACK OF INVESTIGATIVE INFORMATION, WE CANNOT ISOLATE A ROOT CAUSE OF THE MALFUNCTION. AS OUR DUE DILLIGENCE WE ARE REPORTING THIS INCIDENT IN ACCORDANCE TO 21 CFR 803.

    Description of Event or Problem · 0

    PROSOMNUS SLEEP TECHNOLOGIES RECEIVED MEDWATCH # MW5167639 DIRECTLY FROM F.D.A. / C.D.R.H. ON MARCH 25TH, 2025, BELOW IS THE EVENT DESCRIPTION RE-COPIED FROM THE REPORT. PATIENT WAS REMOVING THE PROSOMNUS EVO ORAL SLEEP APPLIANCE AND A SMALL CLIP ON THE MANDIBULAR APPLIANCE BROKE OFF OUTSIDE THE MOUTH. POTENTIAL CHOKING/ASPIRATION EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31065 PROSOMNUS SLEEP AND SNORE DEVICE MANDIBULAR ADVANCEMENT DEVICE LRK PROSOMNUS SLEEP TECHNOLOGIES 1450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other