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 06/25/2014

Event Type  malfunction  

Event Description

Consumer indicated the glue does not stick on the extra comfort night protector.She said she almost choked on it.She said she followed the directions.She said it is a two pack and both did the same thing.She is not satisfied with this product.She confirmed that they were gen ii originals and that both devices in the 2 pk delaminated.The first one delaminated after a few weeks of use.She super glued the two layers together, but it didn't work.She did wake up due to choking on one of them after it had separated in her sleep.

Manufacturer Narrative

This complaint has not been confirmed.Device not returned to mfr.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: 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: 4002328
• MDR Text Key: 4773285
• Report Number: 1825660-2014-00871
• 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: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• 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: 040835
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2014
• 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