MAUDE Adverse Event Report: RANIR LLC REST ASSURED; BRUXISM MOUTHGUARD

Device Problem Material Separation (1562)

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

Event Date 11/16/2015

Event Type  malfunction  

Event Description

Mouthguard came apart during fitting process while in the boiling water.

• Brand Name: REST ASSURED
• Type of Device: BRUXISM MOUTHGUARD
• 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 Key: 5301962
• MDR Text Key: 34328035
• Report Number: 1825660-2015-00114
• 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: company representative,consum
• Reporter Occupation: Device Unattended
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• 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 Received: 11/16/2015
• 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: Initial
• Patient Sequence Number: 1