MAUDE Adverse Event Report: RANIR LLC STOP GRINDING MOUTHGUARD; BRUXISM MOUTH GUARD

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/12/2015

Event Type  Injury  

Event Description

Mother reported, her son may have swallowed the mouthguard.

Manufacturer Narrative

Device not returned.

• Brand Name: STOP GRINDING MOUTHGUARD
• Type of Device: BRUXISM MOUTH GUARD
• Manufacturer (Section D): RANIR LLC; 4701 east paris se; grand rapids MI 49512 535
• Manufacturer (Section G): RANIR LLC; 4701 east paris se; grand rapids MI 49512 535
• Manufacturer Contact: elsa baker ; 4701 east paris ave se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 4907974
• MDR Text Key: 6026924
• Report Number: 1825660-2015-00077
• 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: Company Representative
• Reporter Occupation: Device Unattended
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 07/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Device Unattended
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other