MAUDE Adverse Event Report: RANIR LLC REST ASSURED; MOUTHGUARD, OVER-THE-COUNTER

Model Number REST ASSURED EXTRA COMFORT UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Tingling (2171)

Event Date 11/02/2016

Event Type  No Answer Provided  

Event Description

It swelled my mouth up and tingle.It only lasted 15 minutes that is all.

• Brand Name: REST ASSURED
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer (Section G): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer Contact: rebekah stenske ; 4701 east paris ave. se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 6138917
• MDR Text Key: 61243045
• Report Number: 1825660-2016-00046
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• PMA/PMN Number: K133423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Device Unattended
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Device Unattended
• Device Model Number: REST ASSURED EXTRA COMFORT UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/03/2016
• Date Manufacturer Received: 11/03/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1