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U.S. Department of Health and Human Services

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

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RANIR LLC NITE GUARD; MOUTHGUARD, OVER THE COUNTER Back to Search Results
Model Number GEN II
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Choking (2464)
Event Date 09/03/2013
Event Type  Injury  
Event Description
Consumer reported i checked the packaging and did not find anything indicating that the product had latex in it.Although i did not see anything indicating that it was latex-free either.At any rate, the product must have latex in it.I used it last night when i went to bed at 10 pm, and by 10:45 pm i was awake with a burning sensation in my mouth, blisters forming on my tongue and on the inside of the lips and having difficulty breathing (choking).Consumer followed up saying she is now using our ready-to-wear product.Product was returned to store for refund.
 
Manufacturer Narrative
The product was not returned to the mfr 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, an investigation determined that latex finger cots were used in packaging of this product.A correction action was performed to remove latex from the manufacturing process, and from the factory.
 
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Brand Name
NITE GUARD
Type of Device
MOUTHGUARD, OVER THE COUNTER
Manufacturer (Section D)
RANIR LLC
4701 e paris ave se
grand rapids MI 49512
Manufacturer Contact
4701 east paris ave. s.e.
grand rapids, MI 49512
6166988880
MDR Report Key3692828
MDR Text Key19200402
Report Number1825660-2014-00013
Device Sequence Number1
Product Code OBR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091792
Number of Events Reported1
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 Received03/18/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberGEN II
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/03/2013
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 Number1
Patient Outcome(s) Life Threatening;
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