MAUDE Adverse Event Report: RANIR LLC; MOUTHGUARD, OVER-THE-COUNTER

Model Number MTH GD STP GRNDNG 1CT CA

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2021

Event Type  malfunction  

Event Description

Consumer stated: "my dentist said that i might want to consider using a mouth guard to help.Me stop grinding my teeth.I saw this yesterday and thought that this would be a good temporary till i get a mouth guard.I believe that i swallowed the mouth guard in my sleep." we spoke with the consumer and she was experiencing no discomfort in her throat,.We asked her to confirm that guard had not fallen out of her mouth and was in her bed.She said she looked around her room for the guard and will keep an eye out for it.Consumer did not call back to confirm if she found the guard.

• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer (Section G): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer Contact: rebekah hamilton ; 6166988880
• MDR Report Key: 11313559
• MDR Text Key: 232858627
• Report Number: 1825660-2021-00906
• Device Sequence Number: 1
• Product Code: OBR
• UDI-Device Identifier: 5108030751
• UDI-Public: 5108030751
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K094020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MTH GD STP GRNDNG 1CT CA
• Device Lot Number: 010419
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/12/2021
• Date Manufacturer Received: 01/12/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1