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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THE DOCTOR'S NIGHTGUARD

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THE DOCTOR'S NIGHTGUARD Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Discomfort (2330); Difficulty Chewing (2670); No Code Available (3191)
Event Date 02/01/2012
Event Type  Injury  
Event Description
Just shortly after using the nightguard (which was molded properly as per the instructions) nightly for a few weeks, i developed an open bite, in which i could no longer touch my front teeth together, making chewing difficult and causing overall discomfort.I had to pay a lot of money to fix the open bite with braces.
 
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Brand Name
THE DOCTOR'S NIGHTGUARD
Type of Device
NIGHTGUARD
MDR Report Key6158039
MDR Text Key62103177
Report NumberMW5066615
Device Sequence Number1
Product Code MQC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Type of Device Usage N
Patient Sequence Number1
Treatment
OTC MEDS: NONE. ; RX MEDS: NONE.
Patient Outcome(s) Disability;
Patient Age18 YR
Patient Weight50
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