MAUDE Adverse Event Report: RANIR, LLC REST ASSURED, GEN II; MOUTH GUARD

Model Number REST ASSURED, GEN II

Device Problem Break (1069)

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

Event Date 09/08/2014

Event Type  malfunction  

Event Description

This event happened in (b)(6).She is a long time user and the first night she used this one, she woke up with it broken.  she indicated that she is not a heavy grinder.  this is the first time this has happened.  i asked her to send us the device for investigation.After 30 days the device has not been returned.

Manufacturer Narrative

She is a long time user and the first night she used this one, she woke up with it broken.  she indicated that she is not a heavy grinder.  this is the first time this has happened.  i asked her to send us the device for investigation.After 30 days the product has not been returned.

• Brand Name: REST ASSURED, GEN II
• Type of Device: MOUTH GUARD
• Manufacturer (Section D): RANIR, LLC; 4701 east paris avenue se; grand rapids MI 49512
• Manufacturer (Section G): RANIR, LLC; 4701 east paris avenue se; grand rapids MI 49512
• Manufacturer Contact: elsa baker ; 4701 east paris avenue se; grand rapids, MI 49512 ; 6166988880
• MDR Report Key: 4155841
• MDR Text Key: 4770148
• Report Number: 1825660-2014-00923
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: REST ASSURED, GEN II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2014
• Initial Date FDA Received: 10/09/2014
• 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: Reuse
• Patient Sequence Number: 1