BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSOMNUS EVO SLEEP AND SNORE DEVICE

    MDR report key: 19378252 · Received May 22, 2024

    Report

    Report Number
    3013116677-2024-00002
    Event Type
    Injury
    Date Received
    May 22, 2024
    Date of Event
    April 7, 2024
    Report Date
    May 22, 2024
    Manufacturer
    PROSOMNUS SLEEP TECHNOLOGIES
    Product Code
    LRK
    PMA / PMN Number
    K202529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE INITIAL REPORTER, WHO IS ALSO THE PATIENT, REQUESTED TO C.D.R.H. / F.D.A. TO REMAIN CONFIDENTIAL / ANONYMOUS A LOT OF INFORMATION WAS NOT INCLUDED IN MEDWATCH REPORT # MW 5153918, THAT WOULD ALLOW US TO CONDUCT A MORE THOROUGH INVESTIGATION. THE DATA OF SPECIFIC INTEREST TO PROSOMNUS SLEEP TECHNOLOGIES IS THE SERIAL # SECTION (OUR INTERNAL CASE NUMBER) THAT WAS REDACTED ON THE MEDWATCH REPORT # MW 5153918. THIS LIMITS PROSOMNUS SLEEP TECHNOLOGIES' ABILITY TO GATHER DEVICE RELATED INFORMATION. ALSO, INDICATED IN MEDWATCH REPORT # MW 5153918, THE INITIAL REPORTER STATED THE DEVICE WAS AVAILABLE FOR EVALUATION BY THE MANUFACTURER, BUT PROSOMNUS SLEEP TECHNOLOGIES HAS NOT RECEIVED ANY ANONYMOUS OR UNACCOUNTED DEVICE RETURNS. PERHAPS, SINCE EACH DEVICE HAS A UNIQUE AND SPECIFIC CASE NUMBER FOR IDENTIFICATION, THE DEVICE RETURN WOULD BE CONTRARY TO THE INITIAL REPORTER REMAINING CONFIDENTIAL / ANONYMOUS. MEDWATCH REPORT # MW 5153918 SECTION "DEVICE SERVICED BY A THIRD PARTY" IS REDACTED, INDICATING TO PROSOMNUS SLEEP TECHNOLOGIES THAT THERE COULD POSSIBLY BE ALTERATIONS TO THE SPECIFIC DEVICE REPORTED UPON. ASIDE FROM INITIAL TRY-IN AT THE DOCTOR'S / DENTIST'S OFFICE, THERE SHOULD BE NO RATIONALE FOR THIS SPECIFIC DEVICE TO BE "DEVICE SERVICED BY A THIRD PARTY." DEVICE FABRICATION RELIES ON A SCAN OR PHYSICAL IMPRESSION OF THE PATIENT'S ORAL CAVITY AND DENTITION PROVIDED BY A PRESCRIBER; THEREFORE, IF THE BITE OR SCAN IS INCORRECT, THEN THE DEVICE THAT IS MADE PER THE SUBMITTED SCAN MIGHT FIT INCORRECTLY FOR THE PATIENT. IT IS UNKNOWN IF THIS WAS THE SITUATION IN THIS EVENT. THE DEVICE USER MANUAL, AVAILABLE ONLINE, CONTAINS CONTRAINDICATIONS TO PATIENTS WHO HAVE LOOSE TEETH OR ADVANCED PERIODONTAL DISEASE AND WARNINGS OF TOOTH MOVEMENT OR CHANGES IN DENTAL OCCLUSION, GINGIVAL OR DENTAL SORENESS AND PAIN OR SORENESS TO THE TEMPOROMANDIBULAR JOINTS. SIMILARLY, THE DEVICE'S INSTRUCTIONS FOR USE, WHICH PHYSICALLY ACCOMPANY EACH DEVICE, HAS THE SAME EXACT CONTRAINDICATIONS AND WARNINGS ABOVE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE SUCH AS THE CASE NUMBER OR IF THE ACTUAL DEVICE IS RETURNED IN ITS ENTIRETY, PROSOMNUS SLEEP TECHNOLOGIES WILL DO OUR DUE DILIGENCE AND FOLLOW-UP WITH A MORE COMPREHENSIVE INVESTIGATION AND IF NECESSARY A FOLLOW-UP REPORT. ADDITIONALLY, THE CASE NUMBER WOULD INDICATE TO PROSOMNUS SLEEP TECHNOLOGIES THE SPECIFIC DEVICE HISTORY RECORDS (DHR) DATA TO INVESTIGATE FURTHER. THE RETURN OF THE ACTUAL DEVICE WOULD INDICATE TO PROSOMNUS SLEEP TECHNOLOGIES IF THE DESIGN PLAN (PRESCRIPTION) WAS FOLLOWED, IF ANY ALTERATIONS BY PROSOMNUS SLEEP TECHNOLOGIES OR DENTIST/DOCTOR/END-USER OCCURRED, OR IF THE DEVICE WAS DAMAGED IN SOME OTHER WAY. PROSOMNUS SLEEP TECHNOLOGIES ALSO DO NOT KNOW THE PATIENT'S SPECIFIC HEALTH HISTORY, OF CONCERN IS WHETHER HE HAD ALREADY EXPERIENCED PERIODONTOSIS PRIOR TO USE OF THE PROSOMNUS EVO SLEEP AND SNORE DEVICE. OTHER HEALTH FACTORS MAY HAVE POSSIBLY CONTRIBUTED TO THE EVENT SUCH AS THE PATIENT STOPPING MEDICATIONS FOR BLOOD PRESSURE AND HIGH CHOLESTEROL. IF THE PATIENT SUFFERS FROM BRUXISM THIS MAY ALSO PLAY AN IMPORTANT KEY FACTOR IN THE EVENT. PROSOMNUS SLEEP TECHNOLOGIES IS FILING THIS INITIAL REPORT TO MAINTAIN COMPLIANCE TO 21 CFR 803.

    Description of Event or Problem · 0

    U.S. F.D.A. / C.D.R.H PROVIDED THE MANUFACTURER, PROSOMNUS SLEEP TECHNOLOGIES, WITH A MEDWATCH REPORT, MW5153918 ON MAY 1ST, 2024. THE REPORT IS REFERENCED BELOW AND IN ATTACHMENT, THE BELOW IS THE DESCRIPTION OF EVENT OR PROBLEM VERBATIM: DENTAL INFECTION IN BONE NEAR SECOND MOLAR ON LOWER RIGHT. HAPPENED AFTER CONSISTENT USE OVER SEVERAL WEEKS OF THE ORAL ADVANCEMENT TREATMENT / DEVICE FOR SLEEP APNEA WORN OVER THE TEETH. BELIEVED TO BE RELATED TO THE CUSTOM-FITTED PROSOMNUS EVO POTENTIALLY PUSHING DOWN ON A GUM AREA NEAR WHERE THE INFECTION SET IN. INITIATED AUGMENTIN ANTIBIOTICS AFTER SEVERE PAIN DEVELOPED ON SUNDAY (B)(6) 2024. WAS EVALUATED BY DENTIST FRIDAY (B)(6) 2024 AFTER PAIN SUBSIDED FOLLOWING ANTIBIOTIC TREATMENT, BUT SOME TENDERNESS REMAINED ON PROBING OF THE INFECTED AREAS. DONE AT OFFICE OF DR. (B)(6), PERIODONTIST. NO OTHER DEVICES BEING USED. HAD LAST TAKEN ROSUVASTATIN AND METOPROLOL 3/4 WEEKS PRIOR BUT HAD DISCONTINUED / NO ADHERENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1571451 PROSOMNUS EVO SLEEP AND SNORE DEVICE MANDIBULAR ADVANCEMENT DEVICE LRK PROSOMNUS SLEEP TECHNOLOGIES 1450

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Other| R