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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M CENTER3M VARNISH, CAVITYVARNISH, CAVITY 5% SODIUM FLUORIDE [50,000 PPM]

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3M CENTER 3M VARNISH, CAVITY VARNISH, CAVITY 5% SODIUM FLUORIDE [50,000 PPM]   Back to Search Results
Lot Number ALL LOTS
Event Type  Injury   Patient Outcome  Disability,Other
Event Description

To all interested in child safety from hazardous chemicals: it appears legislators have no clue about child/chemical safety when voting to pass atrocious topical fluoride application. We need some well thought out pr to all news outlets to stop, or banish this dangerous new practice! we need to flood the federal consumer safety; which does not handle 'drug applications', anyway, describing the dangers of fluoride varnish application to young children! additionally, definitely file a complaint to fda about safety of 'fluoride varnish' as applied; link to fda complaint form: http://www. Fda. Gov/safety/reportaproblem/default. Htm. Excerpt: "d is for dental assistants. Authorizes dental assistants to apply fluoride to the teeth of school kids, under the "general direction" of a dentist. " here's a description of why there is danger in application of 'fluoride varnish'; especially into any child's body: fluoride varnish is extremely high in ppm of fluoride. Reference ranging 20,000 to usually over 40,000 ppm. Ref: http://www. Accessdata. Fda. Gov/scripts/cdrh/cfdocs/cfpmn/pmn. Cfm. Fluoride varnish is 'highly retentive' for days after application in a child's mouth. Thus, a child can continuously absorb through under tongue 'sublingual absorption' fluoride 24/7 immediately into bloodstream. Fluoride is highly serious 'neurotoxin'; especially in ones bloodstream! sublingual absorption from under the tongue is a common method for delivering a pharmaceutical faster into a patient's bloodstream. Reference your pdr! fluoridated drinking water 'fl' concentration is usually within 0. 7 - 1. 2 parts per million [ppm]. In 2006, a national science foundation/nas committee studying 'fluoride delivered through fluoridated drinking water concluded: "after reviewing research on various health effects from exposure to fluoride, including studies conducted in the last 10 years, this report concludes that epa's drinking water standard for fluorides a maximum of 4 milligrams of fluoride per liter of water -4 mg/l-s does not protect against adverse health effects. Just over 200,000 americans live in communities where fluoride levels in drinking water are 4 mg/l or higher. Children in those communities are at risk of developing severe tooth enamel fluorosis, a condition that can cause tooth enamel loss and pitting. A majority of the report's authoring committee also concluded that people who drink water containing 4 mg/l or more of fluoride over a lifetime are likely at increased risk for bone fractures. " reference link: http://dels. Nas. Edu/dels/rpt_briefs/fluoride_brief_final. Pdf. Every child in public school system is now required by new state law to have a preschool [e. G. Prior to entering kindergarten] dental exam, on or a school. These mandated 'dental exams' may also be when varnish application is recommended, or even perhaps applied. With parent or guardian permission? now with this new pediatric law for state school children now requires that your child have an oral health assessment by may 31, 2008 in kindergarten or first grade. Excerpt: "the assessment requirement can be fulfilled by private dental examination or a screening performed by a licensed or registered dental professional operating within their scope of practice -currently dentists and hygienists-. There is no penalty for failing to comply with the law. A waiver is available and some concern was expressed for a potential unintended consequence that families may be opting out of sealant/varnish programs at the same time they are opting out of the assessment requirement. " above indicates pre-kindergarten young children may be getting overdosed with unsafe high concentration for unknown, varying retention times in mouth, of sealants and/or varnishes! do pediatric dentists, especially over zealous ones, know anything about sublingual absorption as related to putting dangerous fluoride concentrations into any preschool child's mouth? how many preschool children are getting varnishes before, or soon after in kindergarten? a question for the dept. Of health! we need some well thought out pr to all news outlets to stop, or banish fluoride varnishing of children's teeth by outlawing the above dangerous school new 'oral care' practice!.

 
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Brand Name3M VARNISH, CAVITY
Type of DeviceVARNISH, CAVITY 5% SODIUM FLUORIDE [50,000 PPM]
Manufacturer (Section F)
3M CENTER
bldg 260-2a-17
st. paul MN 55144
Manufacturer (Section D)
3M CENTER
bldg 260-2a-17
st. paul MN 55144
Device Event Key1617343
MDR Report Key1571440
Event Key1496028
Report NumberMW5014236
Device Sequence Number1
Product CodeLBH
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 01/02/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Service Personnel
Device LOT NumberALL LOTS
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/01/2010
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

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