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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR, LLC REST ASSURED; NITE GUARD
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RANIR, LLC REST ASSURED; NITE GUARD Back to Search Results
Model Number GEN II ORIGINAL
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/05/2014
Event Type  malfunction  
Event Description
The guard fell apart after only 2 days.
 
Manufacturer Narrative
This complaint has not been confirmed.The device has not been returned to the 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, and medical intervention may be required if the device is swallowed and goes beyond the pharyngeal arch.Device not returned.
 
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Brand Name
REST ASSURED
Type of Device
NITE GUARD
Manufacturer (Section D)
RANIR, LLC
4701 east paris avenue se
grand rapids MI 49512
Manufacturer (Section G)
RANIR LLC
4701 east paris avenue se
grand rapids MI 49512
Manufacturer Contact
paula bojsen
4701 east paris avenue se
grand rapids, MI 49512
6166988880
MDR Report Key4005092
MDR Text Key4959750
Report Number1825660-2014-00899
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 Other
Type of Report Initial
Report Date 08/12/2014
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 ORIGINAL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/05/2014
Initial Date FDA Received08/13/2014
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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