MAUDE Adverse Event Report: PLACKERS MTH GD GNM 16CT; MOUTHGUARD, OVER-THE-COUNTER

Model Number	MTH GD GNM 16CT
Health Effect - Clinical Code	Choking (2464)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Review posted on (b)(6): so disappointed.Rolls in you mouth.Very difficult to keep in place.Not fair to receive a bad product that you must keep.At night they slide around so much it wakes you and the second night i woke up choking on it.Poorly made product.No product returned, no contact info.

• Brand Name: PLACKERS MTH GD GNM 16CT
• Common Device Name: MOUTHGUARD, OVER-THE-COUNTER
• MDR Report Key: 12214369
• Report Number: 1825660-2021-00984
• Device Sequence Number: 14445704
• Product Code: OBR
• UDI-Device Identifier: 00651080651523
• UDI-Public: 651080651523
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 07/22/2021

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 16CT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1