MAUDE Adverse Event Report: RANIR LLC NITE GUARD; MOUTHGUARD, OVER THE COUNTER

Model Number NO BOIL

Device Problem Off-Label Use (1494)

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

Event Date 06/30/2014

Event Type  malfunction  

Event Description

I enclose with this letter 2 night-time protectors.After wearing each one for seven hours, the areas under the bite pads had formed a bubble or blister effect.When i cleaned them, the raised areas filled with water because each had worn through the other bottom layer, allowing a space for bacteria to form.

Manufacturer Narrative

After receipt of the product for investigation, it appears that there is no "bubbling" or voids in the device.This device was molded correctly.The device seems to have been extensively chewed up after the stated "one use" causing the softer bite pad material to be separated from the base material.This device is intended for mild to moderate bruxism, not the severe bruxism of which it appears to have been subjected.This report has not been confirmed, no injury was reported, and no medical attention was sought.This is being reported even though the device was used outside the intended use indicated on the labeling.Chewed up pieces of this device can be aspirated which could cause an injury requiring surgical intervention.

• Brand Name: NITE GUARD
• Type of Device: MOUTHGUARD, OVER THE COUNTER
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. s.e.; grand rapids MI 49512
• Manufacturer Contact: 4701 east paris ave. s.e.; grand rapids, MI 49512 ; 6166988880
• MDR Report Key: 3994144
• MDR Text Key: 18928276
• Report Number: 1825660-2014-00884
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NO BOIL
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/10/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1