MAUDE Adverse Event Report: RANIR LLC EQUATE MTH GD RST ASRD W/TRAY; MOUTHGUARD, OVER-THE-COUNTER

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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Reaction (2414)

Event Date 05/18/2020

Event Type  malfunction  

Event Description

Consumer stated the product (anti bruxism night guard) caused swelling on/inside her lips, her lips also got a little puffy, and dryness near the opening of her mouth, not a huge reaction, but "enough for me to mention it.".

• Brand Name: EQUATE MTH GD RST ASRD W/TRAY
• 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 ; 6166988880
• MDR Report Key: 10133797
• MDR Text Key: 199480653
• Report Number: 1825660-2020-00774
• Device Sequence Number: 1
• Product Code: OBR
• UDI-Device Identifier: 68113113560
• UDI-Public: 68113113560
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133423
• 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: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MTH GD RST ASRD W/TRAY 2CT CD
• Device Lot Number: 287944A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/18/2020
• Date Manufacturer Received: 05/18/2020
• 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