MAUDE Adverse Event Report: RANIR, LLC REST ASSURED READY-TO-WEAR NITE PROTECTOR; MOUTHGUARD, OVER THE COUNTER

Model Number READY-TO-WEAR

Device Problem Delamination (2904)

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

Event Date 04/30/2014

Event Type  malfunction  

Event Description

The consumer indicated that the device was falling apart."the bottom of the protector (the one that is closest to the bottom teeth) is falling apart.That part of it started developing holes and the plastic pieces got in my mouth.The top of the protector closet to my top teeth was fine".

Manufacturer Narrative

This complaint has not been confirmed.Device not returned to mfr, and no lot number info was given so an eval 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, as choking is possible as a result of delamination.

• Brand Name: REST ASSURED READY-TO-WEAR NITE PROTECTOR
• Type of Device: MOUTHGUARD, OVER THE COUNTER
• 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: 3897484
• MDR Text Key: 4425630
• Report Number: 1825660-2014-00834
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112879
• 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: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: READY-TO-WEAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2014
• 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
• Patient Outcome(s): Life Threatening