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

Model Number MTH GD RST ASRD W/TRAY 2CT CD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/19/2021

Event Type  Injury  

Event Description

(b)(4) issue: product pulled a cap off of his tooth and had gating reflexes, noted the disclaimer: if noticing discomfort and such to call us.

• Brand Name: EQUATE MTH GD RST ASRD W/TRAY 2CT CD
• 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: 12358809
• MDR Text Key: 267844287
• Report Number: 1825660-2021-00994
• Device Sequence Number: 1
• Product Code: OBR
• UDI-Device Identifier: 68113113560
• UDI-Public: 68113113560
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MTH GD RST ASRD W/TRAY 2CT CD
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/09/2021
• Date Manufacturer Received: 08/09/2021
• 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