BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNIFIER MEDICAL EXCITE OSA

    MDR report key: 13757448 · Received March 11, 2022

    Report

    Report Number
    MW5108111
    Event Type
    Malfunction
    Date Received
    March 11, 2022
    Report Date
    March 10, 2022
    Manufacturer
    SIGNIFIER MEDICAL TECHNOLOGIES LIMITED
    Product Code
    QNO
    UDI-DI
    05060627480017
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WITHOUT NOTIFYING PATIENTS SIGNIFIER MEDICAL CHANGED ITS SOFTWARE SO THAT THE MOUTHPIECE REQUIRED FOR OBSTRUCTIVE SLEEP APNEA (OSA) THERAPY EXPIRES AT THE END OF 90 DAYS. EACH NEW MOUTHPIECE PURCHASED NOW EXPIRES 90 AFTER FIRST USE. WITH THE OSA TREATMENT DEVICE. SIGNIFIER MEDICAL REPLIED TO ME VIA EMAIL THAT FDA MANDATED THEM TO MAKE THE DEVICE EXPIRE AT THE END OF 90 DAYS. UNTIL MADE TO EXPIRE, I USED MY INITIAL MOUTHPIECE SUPPLIED WITH THE DEVICE SAFELY FOR APPROXIMATELY 11 MONTHS. I DID NOT SUFFER ILL EFFECTS AND THE DEVICE WORKED THE SAME AS WHEN NEW, I DON'T BELIEVE THE FDA MANDATED EXPIRATION OF THE MOUTHPIECE AFTER 90 DAYS. THIS WAS DONE SOLELY TO SELL ADDITIONAL MOUTHPIECES IN ORDER TO MAKE MORE MONEY. THE SIGNIFIER MEDICAL EXCITE OSA DEVICE WAS APPROVED BY THE FDA. IT IS NOT HOWEVER, COVERED UNDER MEDICARE OR INSURANCE COMPANIES AT PRESENT. HAVING TO BUY A NEW MOUTHPIECE EVERY 90 DAYS WILL BE A FINANCIAL BURDEN ON MANY USERS. WHAT I WOULD LIKE FOR THE FDA TO DO IS REPLY WITH WHETHER OR NOT THERE IS A REQUIREMENT BY THE FDA TO MAKE THE MOUTHPIECE EXPIRE AT THE END OF 90 DAYS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46754 SIGNIFIER MEDICAL EXCITE OSA NEUROMUSCULAR TONGUE MUSCLE STIMULATOR FOR THE REDUCTION OF SNORING QNO SIGNIFIER MEDICAL TECHNOLOGIES LIMITED 05060627480017

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male ANDROGEL 1% 5MG PACKET| ASPIRIN 81 MG| CLOPIDOGREL 75 MG| LOSARTAN 12.5 MG| ROSUVASTATIN 20 MG| SIGNIFIER MEDICAL EXCITE OSA SLEEP APNEA DEVICE| TADALFIL 5 MG