BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAP

    MDR report key: 24059408 · Received January 13, 2026

    Report

    Report Number
    MW5182205
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    February 18, 2025
    Report Date
    January 7, 2026
    Manufacturer
    AIRWAY MANAGEMENT INC.
    Product Code
    LRK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 3/24/2026 FOR REPORT MW5182205 TO UPDATE THE PROCODE TO LRK, BRAND NAME OF THE DEVICE AND MANUFACTURER.

    Description of Event or Problem · 0

    I WAS REFERRED TO A DENTIST WHO SPECIALIZED IN DENTAL APPLIANCE TO TREAT SLEEP APNEA. THIS DEVICE IS REFERRED TO AS NOCTURNAL MANDIBULAR REPOSITIONING APPLIANCE (MAD/OAT). I HAD A SLEEP APNEA TEST USING A "RING" ATTACHED TO THE FINGER. THE RESULTS SAID I HAD MODERATE OBSTRUCTIVE SLEEP APNEA. THE DENTIST FAILED TO DISCLOSE THAT HE OWNS THE SLEEP STUDY COMPANY. I FELT THE REPORT WAS FRAUDULENT AND I SOUGHT ANOTHER OPINION AND DO NOT HAVE SLEEP APNEA. THE DENTIST USED THE SLEEP STUDY REPORT TO SELL ME AND MY INSURANCE A "GADGET" THAT HE MANUFACTURES THAT ADJUSTS THE ORAL AIRWAY TO TREAT MODERATE OBSTRUCTIVE SLEEP APNEA. THE GADGET COSTS (B)(4) AND THE GADGET LOCKS YOUR TEETH TOGETHER AND USES A TURNKEY TO PUSH YOUR TEETH AND JAW LINE OVER TIME. IT WAS VERY CHALLENGING TO REMOVE THE SEAL FROM THE TEETH. I TRIED TO LOOK UP THE DENTIST'S DEVICE, WHICH WAS FDA APPROVED, AND WAS UNABLE TO FIND IT. THIS GADGET IS MANUFACTURED BY THE DENTIST, SOLD BY THE DENTIST, AND THE SLEEP STUDY THAT WOULD COVER THE COST WITH INSURANCE IS OWNED BY THE DENTIST. MY CONCERN HERE IS WHEN I WENT FOR A FOLLOW-UP X-RAY WITH MY REGULAR DENTIST, SHE ASKED ME IF I HAD BEEN PUNCHED IN THE TEETH. THERE WAS SHADOWING IN THE GUMLINE ON X-RAY THAT DEMONSTRATED DAMAGE TO THE TEETH AND GUMLINE. I ATTRIBUTED THE DAMAGE TO THE GADGET SINCE I WAS NOT "HIT" BY ANYTHING TO CAUSE ANY DAMAGE. I WOULD LIKE THE FDA TO INVESTIGATE THIS DENTIST WHO HAS MANUFACTURED THIS DEVICE, IS SELLING THIS DEVICE TO PATIENTS, AND THE DEVICE, IF NOT FDA APPROVED, CAN POTENTIALLY HARM PATIENTS' TEETH. I ALSO THINK THE "RING" USED TO CONDUCT THE SLEEP APNEA TEST WAS ALSO NOT FDA APPROVED AS A WEARABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125666 TAP DEVICE, ANTI-SNORING LRK AIRWAY MANAGEMENT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention