MAUDE Adverse Event Report: MPOWRX HEALTH AND WELLNESS PRODUCTS 2012 INC. GOOD MORNING SNORE SOLUTION

Model Number 2961

Event Date 07/08/2013

Event Type  Injury  

Event Description

This is about the product, currently fda approved, called the good morning snore solution. It is a plastic mouthpiece that holds the tongue in place. The advertisements for this product do not indicate that it uses a plastic piece to hold the tongue in place making it, in my case, impossible to swallow. I'm hoping that you will reconsider your approval of this device as i nearly choked to death on the product. There is no disclosure of this "tongue trap" on its advertisements. And you only find out about it after you've purchased the product. In my experience with it, i nearly choked to death as you cannot swallow and slowly build up saliva in the mouth that eventually backflows and clogs your windpipe. It is dangerous.

• Brand Name: GOOD MORNING SNORE SOLUTION
• Type of Device: GOOD MORNING SNORE SOLUTION
• Manufacturer (Section D): MPOWRX HEALTH AND WELLNESS PRODUCTS 2012 INC.; 31 st nw; calgary, alberta T2L 2K7; CANADA T2L 2K7
• MDR Report Key: 3226645
• Report Number: MW5030864
• Device Sequence Number: 1
• Product Code: LRK
• Report Source: Voluntary
• Reporter Occupation: PATIENT
• Type of Report: Initial
• Report Date: 07/09/2013

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/09/2013
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: 2961
• Device Catalogue Number: 2961
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No
• Is this a Reprocessed and Reused Single-Use Device?: No

Patient TREATMENT DATA

Date Received: 07/09/2013 Patient Sequence Number: 1