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

Model Number GEN II

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Choking (2464)

Event Date 10/18/2013

Event Type  Injury  

Manufacturer Narrative

The product was not returned so that an investigation could be performed.Product was returned to the retail outlet, but cannot be located.Consumer did not seek medical attention.This product does not contain latex or silicone.However, the consumer reported that she is allergic to one of the components of the device, so this is being reported as a potential serious injury.

Event Description

Complaint received by voicemail on friday, (b)(6) 2012 at 3:23 pm.The individual was inquiring if the nite protector contains acrylic, as she is "violently allergic to acrylic." an investigation into the materials was conducted by customer complaints.On (b)(6), 9:12 am, i called the consumer.Consumer explained that she had already tried the protector, experienced a severe burning sensation in her mouth and removed the protector due to the irritation.She then put back in her old protector.The consumer did not seek medical attention for the burning reaction.She indicated that she took the product back to the store for a refund.We discussed that it contained eva, ethylene vinyl acetate.She said that the irritation must be from the acetate, since she is also allergic to acetate, among other things.She had not stated her allergy to acetate in the original voicemail.

• Brand Name: 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: 3692854
• MDR Text Key: 21272554
• Report Number: 1825660-2014-00014
• 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: 03/17/2014

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
• Device Model Number: GEN II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2013
• 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