MAUDE Adverse Event Report: APNEA SCIENCES SNORERX

Model Number SNORERX

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 02/11/2017

Event Type  Injury  

Event Description

Purchased snore rx (b)(6) 2017.Followed instructions on its preparation as later confirmed by company.Within 2 weeks, my two lower front teeth moved forward to where they hit against upper front teeth when i bite or close my mouth.Discontinued use of the product (b)(6) 2017 and contacted company monday (b)(6) 2017.Tooth movement was confirmed by my dentist and x-rays.My dentist has offered to speak with them, and authorized sharing of the x-rays.They have not returned my dentist office calls nor emails.Solution to dental problem was to get invisalign braces costing (b)(6).Company consults with its own advisors who claim this is impossible yet the x-rays demonstrate the issue.They made token offer of (b)(6) for the invisalign assessment visit.The potential of tooth movement is not disclosed on their website.It does exist in the instructions accompanying the product on one line in very small print though it is buried in latter part of ifu after claims and prep instructions.Product can only be purchased through website or via a phone call from company.Questions on website do not mention tooth movement.After issue developed i uncovered the product is approved for sale by fda as a prescription item from a dentist/doctor, ref k153200.I never saw a doctor/dentist for a prescription nor gave company a prescription.Company told me the company generates a prescription for me based upon my answers to nine questions however they never disclosed this business practice.Product was returned to company to their direction to assessment and they confirm i prepped it correctly.The company is at a minimum, advertising outside bounds of product clearance by writing a prescription for me without my knowledge, and not clearly disclosing potential side effects in its literature, website and tv advertising.

• Brand Name: SNORERX
• Type of Device: SNORERX
• Manufacturer (Section D): APNEA SCIENCES
• MDR Report Key: 6584660
• MDR Text Key: 75855211
• Report Number: MW5069925
• Device Sequence Number: 1
• Product Code: LRK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SNORERX
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 73