MAUDE Adverse Event Report: RANIR, LLC GRIND GUARD; BRUXISM DEVICE

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

Patient Problem Foreign Body In Patient (2687)

Event Date 11/14/2013

Event Type  Injury  

Event Description

She had swallowed her nite guard which required an endonoscopy and several medical bills.

Manufacturer Narrative

This has not been confirmed by a medical professional.Product was not returned to manufacturer for investigation, no ot number was given, so an investigation could not be performed.Consumer required medical intervention.It is possible that this is our device under the brand name "grind no more", but consumer reported it as "grind guard." not certain that this is our device.The devices are similar.

• Brand Name: GRIND GUARD
• Type of Device: BRUXISM DEVICE
• Manufacturer (Section D): RANIR, LLC; 4701 east paris ave. s.e.; grand rapids MI 49512
• Manufacturer Contact: 4701 east paris ave. s.e.; grand rapids, MI 49512 ; 6166988880
• MDR Report Key: 4129173
• MDR Text Key: 4923066
• Report Number: 1825660-2014-00815
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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