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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JASON SNORERX; MOUTHGUARD
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JASON SNORERX; MOUTHGUARD Back to Search Results
Model Number SNORERX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Skin Inflammation (2443)
Event Date 09/21/2013
Event Type  Other  
Event Description
Patient reported some temporary jaw pain and skin inflammation around mouth.Never needed medical care of any kind.
 
Manufacturer Narrative
Product manufactured to specifications and was conforming.No other patient has ever reported such an issue.Patient's wife on (b)(6) 2013 said her husband never said he had an issue and he appeared fine.He never rec'd any medical care of any kind.Patient is a (b)(6) for glaxo smith kline.Deemed file closed with no action necessary on (b)(4) 2014.
 
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Brand Name
SNORERX
Type of Device
MOUTHGUARD
Manufacturer (Section D)
JASON
11441 markon drive
Manufacturer Contact
11441 markon drive
garden grove, CA 92641
MDR Report Key3750182
MDR Text Key15127887
Report Number3009549393-2014-00001
Device Sequence Number1
Product Code OBR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Not Applicable
Remedial Action Other
Type of Report Initial
Report Date 01/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberSNORERX
Device Lot Number20140416
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/09/2013
Date Manufacturer Received12/09/2012
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberCLOSED 12-12-13
Patient Sequence Number1
Patient Age55 YR
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