MAUDE Adverse Event Report: RANIR LLC NITE GUARD; MOUTHGUARD, OVER THE COUNTER

Model Number GEN II ORIG

Device Problem Delamination (2904)

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

Event Date 07/03/2014

Event Type  malfunction  

Event Description

Product began splitting in half where the layers meet after a week of nightly wear.

Manufacturer Narrative

This complaint has not been confirmed.Device not returned to mfr.No injury was reported, no med attention was reported to have been sought.This is being reported as a possible delamination, as coking is possible as a result of delamination.

• Brand Name: NITE GUARD
• 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: 4016989
• MDR Text Key: 4695295
• Report Number: 1825660-2014-00895
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: GEN II ORIG
• Device Lot Number: LOT: 071433B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/03/2014
• 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