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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 GRIND NO MORE
Device Problem Delamination (2904)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/03/2012
Event Type  malfunction  
Event Description
Customer reported to their management and product buyer that they are returning the guard after one nights use.State that she awoke in the middle of the night gagging on the guard as it had slipped inside my mouth.
 
Manufacturer Narrative
This report is from(b)(6).This complaint has not been confirmed.The device not returned to manufacturer, and no lot number information was given so an evaluation cannot be performed as to the root cause or actual nature of the problem.No injury was reported, no medical attention was reported to have been sought as a result of swallowing 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 Key4128607
MDR Text Key4941322
Report Number1825660-2014-00799
Device Sequence Number1
Product Code OBR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091175
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 04/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberGRIND NO MORE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/07/2012
Initial Date FDA Received05/01/2014
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
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