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

Model Number	MTH GD GNM 10CT
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer stated she has been using plackers night guards for at least 5 months.She said she swallowed it.When she woke up, it wasn¿t in her mouth any more.It¿s never happened before.She has no discomfort or feeling that it is in her throat.Informed consumer to let us know if the guard was found later in her 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: 11101436
• Report Number: 1825660-2020-00880
• Device Sequence Number: 19056841
• 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
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/31/2020

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 GNM 10CT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 12/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1