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

Model Number GEN III

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 05/29/2014

Event Type  Injury  

Event Description

"can you tell me what this nite guard is made of? i know it does not have latex or silicone but what does it have? i have had an allergic reaction to it and i need to find out what to avoid.Thank you.My reactions were- my tongue became inflamed/red - like a burning feeling and the inside of my lip became all sort of puckery.I though it was a food reaction but i tried eliminating many foods to see if the symptoms changed, but they did not- it was not until i stopped wearing the night guard that they disappeared.".

Manufacturer Narrative

Consumer had what appeared to be an allergic reaction to the device.Because the reaction involved inflammation and burning sensation in the oral cavity it is considered to be a serious injury, even if only temporary in nature, and is a reportable event.Consumer did not seek medical attention, and any known allergies by consumer have not been confirmed.The product was not returned to manufacturer so an evaluation cannot be performed as to the root cause.

• Brand Name: NITE PROTECTOR
• 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: 3912910
• MDR Text Key: 16302836
• Report Number: 1825660-2014-00854
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120103
• 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: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: GEN III
• Device Lot Number: 060512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2014
• Initial Date FDA Received: 06/10/2014
• 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
• Patient Outcome(s): Life Threatening