MAUDE Adverse Event Report: RANIR LLC PLACKERS MTH GD GNM; MOUTHGUARD, OVER-THE-COUNTER

Model Number	MTH GD GNM 10
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer stated: i¿ve been using these for about a week.I woke up this morning, and the guard was missing.I checked all around and under the bed.No guard.I¿m guessing i swallowed it while i was asleep.Consumer didn't respond whether or not he found the guard in his bed.

• Brand Name: PLACKERS MTH GD GNM
• 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: 11464159
• Report Number: 1825660-2021-00916
• Device Sequence Number: 12076670
• Product Code: OBR
• UDI-Device Identifier: 00651080651516
• UDI-Public: 651080651516
• Combination Product (Y/N): N
• PMA/510(K) Number: K094020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2021

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 GNM 10
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2021
• Initial Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1