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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR CORPORATION NITE GUARD; MOUTHGUARD, OVER THE COUNTER
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RANIR CORPORATION NITE GUARD; MOUTHGUARD, OVER THE COUNTER Back to Search Results
Model Number GEN II ORIG
Device Problem Delamination (2904)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/27/2014
Event Type  malfunction  
Event Description
He used it and followed the directions and the product fell apart.After he placed it in the hot water for about 30 minutes as in the instructions, that's when it fell apart and he wasn't able to make an impression or use it.
 
Manufacturer Narrative
This event happened in (b)(6).This complaint has not been confirmed.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.This is being reported as a possible delamination, as choking is possible as a result of delamination.
 
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Brand Name
NITE GUARD
Type of Device
MOUTHGUARD, OVER THE COUNTER
Manufacturer (Section D)
RANIR CORPORATION
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 Key4128563
MDR Text Key4943995
Report Number1825660-2014-00771
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 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 NumberGEN II ORIG
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/27/2014
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
Patient Outcome(s) Life Threatening;
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