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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Date 04/15/2013

Event Type  Injury  

Event Description

I bought two of these and my daughter almost choked to death on one of them.If i had not heard her in the middle of the night and administered what i learned in cpr she may have.The piece is too small for the mouth overnight and not sturdy enough.I have spoken with an attorney and against his advice.Am contacting you because i believe that this product needs to be recalled.I am not interested in making money.I am interested in no one dying from choking.

Manufacturer Narrative

Third party testing indicates that this product is not a chocking hazard.Test results show that the device can enter the oropharynx; however, the geometry does not allow for any potential of complete seal in this area.The mouth guard can become lodged in the oral cavity, potentially causing discomfort to the user, and may elicit a gag reflex and "could be interpreted by users as a hazardous situation leading to a perception of hazard manifestation.Such events may cause concern and alarm to the user, but not permanent physical injury.However, if the device goes beyond the palatopharyngeal arch, surgical intervention may be required to remove the object.Because of the potential for surgical intervention, this is being reported.No injury to the consumer was reported, and no medical attention was sought.No device malfunction.

• 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: 3692850
• MDR Text Key: 4255485
• Report Number: 1825660-2014-00012
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening