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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR, LLC REST ASSURED, GEN II; MOUTH GUARD
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RANIR, LLC REST ASSURED, GEN II; MOUTH GUARD Back to Search Results
Model Number REST ASSURED, GEN II
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Swelling (2091)
Event Date 10/02/2014
Event Type  malfunction  
Event Description
Her lip is swollen after wearing it for an hour or so.Top lip, up into her sinus cavity.Swollen for over 24 hours.Never used mouth piece before.(b)(6) 2014 - spoke with the consumer who confirmed the swelling was localized to her top lip, the area of direct contact with the mouth guard.She stated she took benadryl (diphenhydramine hcl) and the swelling subsided.Her only known allergy is to penicillin.She has not used the product since this first time.
 
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Brand Name
REST ASSURED, GEN II
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 Key4215235
MDR Text Key21882761
Report Number1825660-2014-00940
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 10/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dentist
Device Model NumberREST ASSURED, GEN II
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Home
Date Manufacturer Received10/02/2014
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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