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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR, LLC NITE GUARD; MOUTHGUARD, OVER THE COUNTER
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RANIR, LLC NITE GUARD; MOUTHGUARD, OVER THE COUNTER Back to Search Results
Model Number GEN II REDESIGN
Device Problem Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/02/2014
Event Type  malfunction  
Event Description
I was using the device for approx.Two weeks.I didn't realize how much i was clenching my teeth.I was not total fitting correctly and i swallowed the device in my sleep.What are the precautions i should do? there was some pain in the lower throat but now has left up.Can the device totally melt and resolved?.
 
Manufacturer Narrative
No additional info is given by the consumer.No lot code was given, no product was returned for investigation.No injury was reported, no medical attention was sought.This is being reported because if the device is swallowed, medical attention may be necessary to remove the device.
 
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Brand Name
NITE GUARD
Type of Device
MOUTHGUARD, OVER THE COUNTER
Manufacturer (Section D)
RANIR, LLC
4701 east paris ave. s.e.
grand rapids MI 49512
Manufacturer Contact
4701 east paris ave. s.e.
grand rapids, MI 49512
6166988880
MDR Report Key3905746
MDR Text Key4673803
Report Number1825660-2014-00836
Device Sequence Number1
Product Code OBR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091792
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberGEN II REDESIGN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/02/2014
Initial Date FDA Received05/27/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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