MAUDE Adverse Event Report: RANIR LLC PLACKERS MTH GD GNM 10CT; MOUTHGUARD, OVER-THE-COUNTER

Model Number MTH GD GNM 10CT

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/04/2021

Event Type  malfunction  

Event Description

I know the box says one size fits all, but i went to sleep with one in and woke up with it in the back of my throat, my wife pulled it out and i tried it again.When i woke up the second time i could feel it in my throat, i swallowed it again.

• Brand Name: PLACKERS MTH GD GNM 10CT
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave, se; grand rapids MI 49512 5353
• MDR Report Key: 12614712
• MDR Text Key: 281530134
• Report Number: 1825660-2021-01014
• Device Sequence Number: 1
• Product Code: OBR
• UDI-Device Identifier: 00651080651516
• UDI-Public: 651080651516
• Combination Product (y/n): N
• PMA/PMN Number: K094020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MTH GD GNM 10CT
• Device Lot Number: 78500
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/04/2021
• Date Manufacturer Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1