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
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Reaction (2414)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The consumer explained that after 10 days, she was awakened by "pains her mouth and immediately removed the protector.When she awoke the next morning, one side of her face was swollen.I obviously had a reaction to wearing the protector.The swelling eased after ice packs and a week of mild inflammatory tablets.

• Brand Name: EQUATE MTH GD RST ASRD W/TRAY
• Common Device Name: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• MDR Report Key: 10022062
• Report Number: 1825660-2020-00760
• Device Sequence Number: 2728879
• Product Code: OBR
• UDI-Device Identifier: 00681131135603
• UDI-Public: 681131135603
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K133423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MTH GD RST ASRD W/TRAY 2CT CD
• Device Lot Number: 282576A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1