MAUDE Adverse Event Report: RANIR LLC REST ASSURED NITE PROTECTOR - GEN II REDESIGN; 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

Got a bunch of implants in my teeth.The middle part (of the mouth guard) broke in two; the upper one.And it did the same thing.The pieces in the back were hard and were clinging in the teeth.

• Brand Name: REST ASSURED NITE PROTECTOR - GEN II REDESIGN
• 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: 5676816
• MDR Text Key: 45887385
• Report Number: 1825660-2016-00045
• 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: Other
• 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
• Event Location: Home
• Date Manufacturer Received: 05/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1