MAUDE Adverse Event Report: RANIR, LLC GRIND NO MORE; NITE GUARD OTC

Model Number GRIND NO MORE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Irritation (2076)

Event Date 11/03/2014

Event Type  Injury  

Event Description

I recently used the placers night guard for 2 nights in a row and developed blisters on the upper area of my cheeks.I am wondering what they are made out of so i can avoid the same thing in other products.Are they by chance silicone or polyethylene?.

Manufacturer Narrative

I recently used the placers night guard for 2 nights in a row and developed blisters on the upper area of my cheeks.I am wondering what they are made out of so i can avoid the same thing in other products.Are they by chance silicone or polyethalene?".

• Brand Name: GRIND NO MORE
• Type of Device: NITE GUARD OTC
• 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: 4292060
• MDR Text Key: 5268077
• Report Number: 1825660-2014-00964
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091175
• 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: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: GRIND NO MORE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2014
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other