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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC NITE GUARD
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RANIR LLC NITE GUARD 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 11/01/2012
Event Type  malfunction  
Event Description
Consumer complains that she would like a refund.The two layers separated on both guards.I cannot tolerate this.You say satisfaction guaranteed or refund your money on the box which she included in the letter.
 
Manufacturer Narrative
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
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 Key4128435
MDR Text Key4793312
Report Number1825660-2014-00745
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
Date FDA Received05/01/2014
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 Received11/01/2012
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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