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

Model Number	MTH GD RST ASRD W/TRAY 2CT CRTN
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer stated after fitting the first guard and using it for about 3 weeks, the guard broke and split into two during use at the middle where it was very thin.Consumer threw away the guard.

• Brand Name: MEIJER MTH GD RST ASRD W/TRAY 2CT
• 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: 10417982
• Report Number: 1825660-2020-00792
• Device Sequence Number: 4016260
• Product Code: OBR
• UDI-Device Identifier: 00719283190390
• UDI-Public: 719283190390
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MTH GD RST ASRD W/TRAY 2CT CRTN
• Device Lot Number: 287842
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1