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 05/22/2020

Event Type  Injury  

Event Description

Consumer emailed asking if it was possible to be allergic to the material in this product.She wore the anti-bruxism night protector through the night.By morning my cheeks and mouth were puffy and swollen, mainly around cheeks, mouth, and jaw area.What is the product made of? consumer used the (b)(6) and stopped using.

• 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: 10171812
• MDR Text Key: 195711895
• Report Number: 1825660-2020-00778
• Device Sequence Number: 1
• Product Code: OBR
• UDI-Device Identifier: 8113113560
• UDI-Public: 8113113560
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• 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: 288480
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/22/2020
• Date Manufacturer Received: 05/22/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1