BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCITEOSA

    MDR report key: 17230134 · Received June 28, 2023

    Report

    Report Number
    MW5118989
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    June 25, 2023
    Report Date
    June 26, 2023
    Manufacturer
    UNKNOWN
    Product Code
    QNO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE PRODUCT EXCITE FOR SLEEP APNEA. THIS PRODUCT HAS A MOUTHPIECE THAT SELLS FOR (B)(6) EACH AND WORKS ONLY 90 DAYS. THEY ARE PREMATURELY EXPIRING MANY FORCING PATIENTS TO BUY NEW TO INCREASE REVENUES. PLEASE CONDUCT INVESTIGATION ON ITS UNFAIR PRACTICES OF FORCING PATIENTS TO BUY THEIR MOUTHPIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884539 EXCITEOSA NEUROMUSCULAR TONGUE MUSCLE STIMULATOR FOR THE REDUCTION OF SNORING AND OBSTRUCT QNO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other