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

Model Number REST ASSURED, GEN II ORIGINAL

Device Problems Material Separation (1562); Fitting Problem (2183)

Patient Problem Discomfort (2330)

Event Date 10/22/2014

Event Type  malfunction  

Event Description

Patient stated, "after a few months of using the guard, the hard backing separated from the soft area with the teeth impressions." she threw it away and bought another brand, forgetting that she had the 2nd rest assured guard.  recently she found the 2nd ra and fit it.After 2 attempts to get the protector to fit comfortably she realized that it isn't the same as the other brand.It doesn't conform as easily to the roof of her mouth and the hard part is uncomfortable against her tongue.

Manufacturer Narrative

After a few months of using the guard, the hard backing separated from the soft area with the teeth impressions.She threw it away and bought another brand forgetting that she had the 2nd rest assured product.  recently she found the 2nd ra and fit it.After 2 attempts to get the protector to fit comfortably she realized that it isn't the same as the other brand.It doesn't conform as easily to the roof of her mouth and the hard part is uncomfortable against her tongue.

• Brand Name: REST ASSURED, GEN II ORIGINAL
• 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: 4266882
• MDR Text Key: 20322226
• Report Number: 1825660-2014-00945
• 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: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: REST ASSURED, GEN II ORIGINAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Manufacturer Received: 10/22/2014
• 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