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

Device Problem Split (2537)

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

Event Date 01/30/2015

Event Type  No Answer Provided  

Event Description

Mouth guard top split from bottom part.Biting through mouth guard, threw it away.

Manufacturer Narrative

In order to bite through the device as the consumer reported, the consumer would have to be a severe grinder or the device would have been used far beyond the life expectancy.The delamination reported may well be due to excessive wear in this case vs.Device malfunction.

• Brand Name: REST ASSURED NITE GUARD
• Type of Device: BRUXISM MOUTH GUARD
• 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: 4556144
• MDR Text Key: 5474639
• Report Number: 1825660-2015-00019
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Device Unattended
• Type of Report: Initial
• Report Date: 03/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Device Unattended
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Patient Sequence Number: 1