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

Model Number GEN II REDESIGN

Device Problem Delamination (2904)

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

Event Date 07/22/2014

Event Type  malfunction  

Event Description

I would like to have a refund because the gum protector did not fit like it was suppose to.It was damaged (broke).Noticed both protectors in 2 pack had a "crack" before boiling.Describe this as a seam where they were made or put together rather than a defect, and they looked fine and were not separating or coming apart prior to boiling.Put them in the boiling water and after approximately 5 seconds in the boiling water, they came apart - they both just fell apart.

Manufacturer Narrative

This complaint has not been confirmed.Device not returned to manufacturer, and no lot number info was given so an evaluation cannot be performed as to the root cause or actual nature of the problem.No injury was reported, no medical attention was reported to have been sought.This is being reported as a possible delamination, as choking is possible as a result of delamination.

• 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: 4016889
• MDR Text Key: 4877062
• Report Number: 1825660-2014-00888
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133423
• 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: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: GEN II REDESIGN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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