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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 Problem Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2014
Event Type  malfunction  
Event Description
The consumer stated that the first time he did the fit it didn't feel good.When he re-boiled it to try again, it seemed to almost fall apart.He used the second one and it did the same thing.
 
Manufacturer Narrative
The consumer stated that the first time he did the fit it didn't feel good.When he re-boiled it to try again, it seemed to almost fall apart.He used the second one and it did the same thing.
 
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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 Key4343213
MDR Text Key5174618
Report Number1825660-2014-00985
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 12/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2014
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
Date Manufacturer Received12/01/2014
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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