MAUDE Adverse Event Report: RANIR LLC REST ASSURE NITE PROTECTOR; BRUXISM MOUTH PROTECTOR - GEN III

Device Problem Delamination (2904)

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

Event Date 02/09/2015

Event Type  malfunction  

Event Description

Bite guard delaminated into a top and bottom layer.

Manufacturer Narrative

Device not returned to manufacturer.

• Brand Name: REST ASSURE NITE PROTECTOR
• Type of Device: BRUXISM MOUTH PROTECTOR - GEN III
• Manufacturer (Section D): RANIR LLC; 4701 east paris se; grand rapids MI 49512 535
• Manufacturer (Section G): RANIR LLC; 4701 east paris se; grand rapids MI 49512 535
• Manufacturer Contact: elsa baker ; 4701 east paris ave se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 4584032
• MDR Text Key: 5343972
• Report Number: 1825660-2015-00041
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Device Unattended
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Device Unattended
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1