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

Model Number MTH GD RST ASRD W/TRAY 2CT CD

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 07/10/2017

Event Type  Injury  

Event Description

Reporter/patient stated that the eq night guards are causing her to get blisters on her tongue and the inside of her mouth.

• Brand Name: EQUATE
• 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: 6750306
• MDR Text Key: 81271809
• Report Number: 1825660-2017-00126
• 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
• Type of Report: Initial
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Device Unattended
• Device Model Number: MTH GD RST ASRD W/TRAY 2CT CD
• Device Lot Number: 183833B
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/10/2017
• Date Manufacturer Received: 07/10/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1