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

Model Number GRIND NO MORE

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Swelling (2091)

Event Date 11/12/2014

Event Type  Injury  

Event Description

Used the mouth guard for 6 wks.4x woke up with lips swollen.Swelling went down within 4 hrs.

Manufacturer Narrative

This is being reported as a possible allergic response.Medical intervention was not required nor sought.Product not returned to manufacturer so it could not be evaluated specifically but the materials and their handling during packaging were confirmed to be otherwise unsensitizing.

• 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: 4326907
• MDR Text Key: 21493726
• Report Number: 1825660-2014-00963
• 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: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• 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: 11/12/2014
• 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