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

Model Number GEN II ORIG

Device Problem Misassembly by Users (3133)

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

Event Date 02/25/2014

Event Type  malfunction  

Event Description

It needs a hole in the area of the front two teeth to string a piece of floss tied to put around the head to neck.Consumer usually cuts her protectors until it's comfortable.The first protector she bought split it two where the crack is and she glued it together.She wondered if it would be harmful to put in her mouth since she glued it, but then said the glue didn't hold it together.She thinks the product is a good idea.

Manufacturer Narrative

This complaint has not been confirmed.Device not returned to mfr, and no lot number info was given so an eval cannot be performed as to the root cause.However, it does not appear that the consumer purposely cut the device in the area of the frenulum labii superioris in order to get it to fit her mouth.This device is not designed or intended to be modified by the consumer.No injury was reported, no medical attention was reported to have been sought.This is being reported as a device lamination is a reportable malfunction; choking is possible as a result of the delamination.

• Brand Name: NITE GUARD
• Type of Device: MOUTHGUARD, OVER THE COUNTER
• Manufacturer (Section D): RANIR, LLC; 4701 east paris ave. se; grand rapids MI 49512
• Manufacturer Contact: 4701 east paris ave. se; grand rapids, MI 49512 ; 6166988880
• MDR Report Key: 3815883
• MDR Text Key: 4500991
• Report Number: 1825660-2014-00021
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: GEN II ORIG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening