MAUDE Adverse Event Report: RANIR LLC STOP GRINDING; BRUXISM DEVICE

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 05/20/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Device not returned, no malfxn.

Event Description

I think i swallowed the night protector.

• Brand Name: STOP GRINDING
• Type of Device: BRUXISM DEVICE
• Manufacturer (Section D): RANIR LLC; 4701 east paris se; grand rapids MI 49512
• Manufacturer (Section G): RANIR LLC; 4701 east paris se; grand rapids MI 49512
• Manufacturer Contact: elsa baker ; 4701 east paris se; grand rapids 49512 ; 6166988880
• MDR Report Key: 5676756
• MDR Text Key: 45853104
• Report Number: 1825660-2016-00038
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Device Unattended
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1