MAUDE Adverse Event Report: RANIR, LLC GRIND NO MORE; BRUXISM DEVICE

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2013

Event Type  Injury  

Event Description

She has swallowed it and she is concerned that she had it stuck in her throat.She says that she can reel it in her throat and cannot swallow anything.First time using on her first night.She used it late night and when she work up this morning, she tried to drink coffee and she cannot get the coffee to go down her throat.She gagged and the coffee came back up.She is very freaked out and has been told to go to the hospital, but does not want to go.Product was recommended by her dentist and was a perfect fit when she went to bed at night.

Manufacturer Narrative

This complaint has not been confirmed.Device not returned to manufacturer, and no lot number information was given so an evaluation cannot be performed as to the root cause or actual nature of the problem.No medical attention was reported to have been sought, no injury was reported.Consumer did not go to the hospital.This event is being reported as there is the possibility that surgical intervention may be required if the device is swallowed.

• Brand Name: GRIND NO MORE
• 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: 4129167
• MDR Text Key: 4923065
• Report Number: 1825660-2014-00807
• 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: 01/24/2013
• 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): Life Threatening