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

Model Number GEN II ORIGINAL

Device Problem Material Separation (1562)

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

Event Date 07/18/2014

Event Type  malfunction  

Event Description

Consumer states: "i followed the directions explicitly; boil, cool down, avoidance of contact with hot metal, fitting, pressure molding.However, when i tried to use it last night, it came apart.In the part of the arch contacting molars and bicuspids the lip or rim of the device separated from the impressions left by the teeth.".

Manufacturer Narrative

This complaint has not been confirmed.The device has not been returned to the 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 injury was reported, no medical attention was reported to have been sought.This is being reported as a possible delamination, and medical intervention may be required if the device is swallowed and goes beyond the pharyngeal arch.

• Brand Name: REST ASSURED
• Type of Device: MOUTHGUARD, OVER THE COUNTER
• Manufacturer (Section D): RANIR, LLC; 4701 east paris avenue se; grand rapids MI 49512
• Manufacturer (Section G): RANIR LLC; 4701 east paris avenue se; grand rapids MI 49512
• Manufacturer Contact: paula bojsen ; 4701 east paris avenue se; grand rapids, MI 49512 ; 6166988880
• MDR Report Key: 4005042
• MDR Text Key: 16081749
• Report Number: 1825660-2014-00896
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091792
• 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: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: GEN II ORIGINAL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2014
• 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