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

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.

• Brand Name: 3M ESPE VANISH 5% NAF WHITE VARNISH
• Type of Device: CAVITY 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 Key: 1202684
• MDR Report Key: 1172071
• Event Key: 1123359
• Report Number: 2110898-2008-00025
• Device Sequence Number: 1
• Product Code: LBH
• 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 Received: 09/23/2008
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 12147C
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 09/12/2008
• 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