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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMNI ORAL PHARMACEUTICALSVANISH 5%NAF WHITE 5%VARNISH

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OMNI ORAL PHARMACEUTICALS VANISH 5%NAF WHITE 5% VARNISH   Back to Search Results
Event Date 11/07/2007
Event Type  Injury   Patient Outcome  Life Threatening
Event Description

We took our son for a routine dental visit, which was his first cleaning. At this visit, they applied 'vanish varnish' made by omni oral pharmaceuticals a 3m company. Upon application of this product, my son stuck his tongue out and refused to swallow. After the treatment he continued to leave his tongue out of his mouth and to lick anything he could find. Shortly after that, he vomited violently and i noticed his tongue was swollen and whole mouth was very red. The dentist was aware that my son has an allergy to peanuts and most tree nuts and pulled the msds sheet for the product. The ingredients were as follows: ethyl, alcohol, sodium fluoride, hexanes, rosin, and flavorings. There were no allergy warnings. The dentist then called the company and they reluctantly faxed over a toxicology assessment dated 2007, that states a "risk of allergic cross-reactions to colophony contained in vanish varnish in pts with allergic reactions to pine nuts. " there were no allergy warnings on the product packaging and the toxicology report had not been distributed to the dentist. My son's reaction was potentially life threatening. A warning should be required to prevent more reactions in the future. Dates of use: one day in 2007. Diagnosis or reason for use: teeth cleaning. Event abated after use stopped or dose reduced? yes.

 
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Brand NameVANISH 5%NAF WHITE 5%
Type of DeviceVARNISH
Manufacturer (Section F)
OMNI ORAL PHARMACEUTICALS
Manufacturer (Section D)
OMNI ORAL PHARMACEUTICALS
Device Event Key938682
MDR Report Key966153
Event Key927471
Report NumberMW5004691
Device Sequence Number1
Product CodeLBH
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 11/12/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/12/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 11/12/2007 Patient Sequence Number: 1
#TreatmentTreatment Date
ONE DENTAL APPLICATION
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