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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR, LLC REST ASSURED, GEN II ORIGINAL; MOUTH GUARD
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RANIR, LLC REST ASSURED, GEN II ORIGINAL; MOUTH GUARD Back to Search Results
Model Number REST ASSURED, GEN II ORIGINAL
Device Problems Material Separation (1562); Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2014
Event Type  malfunction  
Event Description
The fitting process was hard to do and wasn't quite right.The first protector separated into 2 pieces, top and bottom after the fourth night."the other protector still isn't right.".
 
Manufacturer Narrative
The fitting process was hard to do and wasn't quite right.The first protector separated into 2 pieces, top and bottom after the fourth night."the other protector still isn't right.".
 
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Brand Name
REST ASSURED, GEN II ORIGINAL
Type of Device
MOUTH 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
elsa baker
4701 east paris avenue se
grand rapids, MI 49512
6166988880
MDR Report Key4267201
MDR Text Key14874156
Report Number1825660-2014-00951
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 11/20/2014
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 Dentist
Device Model NumberREST ASSURED, GEN II ORIGINAL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Home
Initial Date Manufacturer Received 10/23/2014
Initial Date FDA Received11/20/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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