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

Device Problem Split (2537)

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

Event Date 08/31/2015

Event Type  malfunction  

Event Description

Mouth guard split down the middle.

• Brand Name: REST ASSURED NITE GUARD
• Type of Device: BRUXISM DEVICE
• 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: 5125396
• MDR Text Key: 27647266
• Report Number: 1825660-2015-00092
• 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
• Reporter Occupation: Other
• Remedial Action: Replace
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2015
• 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