MAUDE Adverse Event Report: RANIR, LLC NITE GUARD; MOUTHGUARD, OTC

Device Problem Delamination (2904)

Patient Problem Choking (2464)

Event Date 02/25/2014

Event Type  malfunction  

Event Description

To whom it may concern, i began using your product in (b)(6) after many years of using other name brand night protectors, unfortunately your night guard came apart at the seem and i woke up last night choking on the bottom half of the guard, i think your product has a real problem, i could have died in my sleep, i live alone and it scared the hell out of me, i am considering hiring a lawyer to look at filing a case against your corp, i will give you 24 hours to respond before i take further action.

Manufacturer Narrative

This complaint has not been confirmed by a medical professional.Consumer was asked to return the device in question so that an investigation can be performed.The device has not been returned to the mfr for eval.No lot code or model was given.This is a reportable malfunction as there is a potential for serious injury.Until we receive the device back for investigation, or we get more info regarding this event, we consider this to be closed.

• Brand Name: NITE GUARD
• Type of Device: MOUTHGUARD, OTC
• 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: 3739182
• MDR Text Key: 4307581
• Report Number: 1825660-2014-00008
• 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: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening