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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR, LLC NITE GUARD; MOUTHGUARD, OVER THE COUTNER
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RANIR, LLC NITE GUARD; MOUTHGUARD, OVER THE COUTNER 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 05/30/2014
Event Type  malfunction  
Event Description
Consumer said that the flat plastic part has come apart.
 
Manufacturer Narrative
This event occurred in (b)(6).This complaint has not been confirmed.Device not returned to mfr, and no lot number info was given so an eval cannot be performed as to the root cause of 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 COUTNER
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 Key3987622
MDR Text Key4637455
Report Number1825660-2014-00853
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 06/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2014
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
Date Manufacturer Received05/30/2014
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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