Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC REST ASSURED NO BOIL; BRUXISM MOUTH GUARD
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

RANIR LLC REST ASSURED NO BOIL; BRUXISM MOUTH GUARD Back to Search Results
Device Problems Physical Property Issue (3008); Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2015
Event Type  malfunction  
Manufacturer Narrative
This complaint was received from a retailer who did not have any consumer contact information.The report as received was not an adverse event report; it was merely a consumer opinion of product durability.There was no report of the device being rendered unusable or an adverse event occurring due to the tear in the device.There is no way to confirm if the consumer intended communication of this case to his retailer as an opinion or as a complaint.Since there have been other changes to mouthguards manufactured by ranir, this event is being reported - in case it was intended as a formal event vs.An opinion of durability.Device not returned.
 
Event Description
Guards are flimsy and tear when you use them.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
REST ASSURED NO BOIL
Type of Device
BRUXISM MOUTH GUARD
Manufacturer (Section D)
RANIR LLC
4701 east paris se
grand rapids MI 49512 5353
Manufacturer (Section G)
RANIR LLC
4701 east paris se
grand rapids MI 49512 5353
Manufacturer Contact
elsa baker
4701 east paris ave se
grand rapids, MI 49512-5353
6166988880
MDR Report Key5271319
MDR Text Key32815302
Report Number1825660-2015-00112
Device Sequence Number1
Product Code OBR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Device Unattended
Type of Report Initial
Report Date 12/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? No
Date Manufacturer Received11/06/2015
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-