MAUDE Adverse Event Report: RANIR LLC REST ASSURED NITE PROTECTOR; BRUXISM MOUTH GUARD

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2016

Event Type  malfunction  

Event Description

Completely fell apart and wouldn't mold to my teeth.I followed the package directions to the letter, even going so far as to time the time in the boiling water, placing it on the plate for 20 seconds, and then placing it in my mouth properly.Neither of the two mouth guards were usable in the end.

• Brand Name: REST ASSURED NITE PROTECTOR
• Type of Device: BRUXISM MOUTH GUARD
• Manufacturer (Section D): RANIR LLC; 4701 east paris se; grand rapids MI 49512
• Manufacturer (Section G): RANIR LLC; 4701 east paris se; grand rapids MI 49512
• Manufacturer Contact: elsa baker ; 4701 east paris se; grand rapids 49512 ; 6166988880
• MDR Report Key: 5676785
• MDR Text Key: 47146298
• Report Number: 1825660-2016-00044
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Device Unattended
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1