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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SCIENTIFIC PHARMACEUTICALS, INC.3M ESPE VANISH 5% NAF WHITE VARNISHCAVITY VARNISH

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SCIENTIFIC PHARMACEUTICALS, INC. 3M ESPE VANISH 5% NAF WHITE VARNISH CAVITY VARNISH   Back to Search Results
Catalog Number 12147C
Event Date 09/10/2008
Event Type  Injury   Patient Outcome  Hospitalization
Event Description

It was reported in 2008, that a female patient had visited her dental office for a routine cleaning followed by an application of 3m espe vanish 5% naf white varnish. After leaving the dental office the patient had difficulty breathing and lost consciousness. Patient was taken to er by her parents; the patient is reported to be fine. No details on the nature of treatment at the er, if any, were provided to 3m espe.

 
Manufacturer Narrative

Results & conclusions: the device was not returned to 3m espe, nor was a lot number provided. Therefore, an evaluation of the specific or similar material was not conducted. Based on the product's favorable evaluation of biocompatibility and its extensive favorable clinical history, effects such as this are not anticipated.

 
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Brand Name3M ESPE VANISH 5% NAF WHITE VARNISH
Type of DeviceCAVITY VARNISH
Manufacturer (Section F)
SCIENTIFIC PHARMACEUTICALS, INC.
3221 producer way
pomona CA 91768
Manufacturer (Section D)
SCIENTIFIC PHARMACEUTICALS, INC.
3221 producer way
pomona CA 91768
Manufacturer Contact
leilani crosby
2501 s.e. otis corely drive
bentonville , AR 72712
(479) 418 -7502
Device Event Key1202684
MDR Report Key1172071
Event Key1123359
Report Number2110898-2008-00025
Device Sequence Number1
Product CodeLBH
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation DENTIST
Type of Report Initial
Report Date 09/19/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number12147C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received09/12/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

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