MAUDE Adverse Event Report: SIGNIFIER MEDICAL TECHNOLOGIES LIMITED SIGNIFIER MEDICAL EXCITE OSA; NEUROMUSCULAR TONGUE MUSCLE STIMULATOR FOR THE REDUCTION OF SNORING

Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
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).

• Brand Name: SIGNIFIER MEDICAL EXCITE OSA
• Common Device Name: NEUROMUSCULAR TONGUE MUSCLE STIMULATOR FOR THE REDUCTION OF SNORING
• Manufacturer (Section D): SIGNIFIER MEDICAL TECHNOLOGIES LIMITED
• MDR Report Key: 13757448
• Report Number: MW5108111
• Device Sequence Number: 3837287
• Product Code: QNO
• UDI-Device Identifier: 05060627480017
• UDI-Public: 5060627480017
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/02/2022
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White