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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPOWRX HEALTH AND WELLNESS PRODUCTS 2012 INC. GOOD MORNING SNORE SOLUTION
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MPOWRX HEALTH AND WELLNESS PRODUCTS 2012 INC. GOOD MORNING SNORE SOLUTION Back to Search Results
Model Number 2961
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Dysphagia/ Odynophagia (1815)
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.

 
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Brand NameGOOD MORNING SNORE SOLUTION
Type of DeviceGOOD MORNING SNORE SOLUTION
Manufacturer (Section D)
MPOWRX HEALTH AND WELLNESS PRODUCTS 2012 INC.
31 st nw
calgary, alberta T2L 2K7
CA T2L 2K7
MDR Report Key3226645
MDR Text Key3652761
Report NumberMW5030864
Device Sequence Number1
Product Code LRK
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
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 Received07/09/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number2961
Device Catalogue Number2961
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
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