MAUDE Adverse Event Report: RANIR LLC MEIJER MTH GD RST ASRD EX COMF 2CT; MOUTHGUARD, OVER-THE-COUNTER

Model Number MTH GD RST ASRD EX COMF 2CT CRTN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Reaction (2414)

Event Date 07/05/2018

Event Type  malfunction  

Event Description

Consumer asked what material is the night guard made of and she believed she was having an allergic reaction to it.On (b)(6) 2018 consumer used the guard three nights and she didn't use the night before she called.She did not have hives in my mouth this morning and the swelling of my lips went down considerably.At first consumer thought she had chapped lips but each day the symptoms grew worse.Later she thought this could be a reaction because the night guard was the only new addition in her life.She has never bought an over the counter night guard before.Benadryl helped with the symptoms, she only needed to take one dose.The product was very easy to use and the instructions were very clear.The fit was great.

• Brand Name: MEIJER MTH GD RST ASRD EX COMF 2CT
• 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: 7738806
• MDR Text Key: 115776251
• Report Number: 1825660-2018-00376
• Device Sequence Number: 1
• Product Code: OBR
• 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: 08/01/2018

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
• Device Operator: Lay User/Patient
• Device Model Number: MTH GD RST ASRD EX COMF 2CT CRTN
• Device Lot Number: 229208
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/05/2018
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 08/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1