• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS3M ESPE VANISH 5% SODIUM FLUORIDE VARNISHVARNISH, CAVITY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

3M ESPE DENTAL PRODUCTS 3M ESPE VANISH 5% SODIUM FLUORIDE VARNISH VARNISH, CAVITY   Back to Search Results
Catalog Number 12145C
Event Date 08/17/2010
Event Type  Injury   Patient Outcome  Life Threatening
Event Description

A (b)(6) male child received a treatment with 3m espe vanish (t) 5% sodium fluoride white varnish treatment followed by routine childhood immunizations 5 minutes later; details on the type of immunizations were not provided to 3m espe, but treatment was provided in a public health nurse office. Within 5 minutes after receiving the immunizations, the child began to experience coughing, wheezing, difficulty breathing and vomiting. Emts responded and administered benadryl and epinephrine to the pt; during transport to the hospital via ambulance, the pt was administered a nebulizer treatment (details on drug administered were not provided to 3m espe). At the emergency room, additional symptoms of mouth/facial redness and a rash on the legs were noted. Pt was administered additional benadryl and was released. Pt was reported to be fine by that same evening.

 
Manufacturer Narrative

Results and conclusions: the device has not been returned to 3m espe, therefore no eval could be conducted. This product has been thoroughly evaluated for biocompatibility and found to be safe for its intended use. The role that the immunizations may have played in this case is not understood.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3M ESPE VANISH 5% SODIUM FLUORIDE VARNISH
Type of DeviceVARNISH, CAVITY
Manufacturer (Section F)
3M ESPE DENTAL PRODUCTS
st. paul MN 55144
Manufacturer (Section D)
3M ESPE DENTAL PRODUCTS
st. paul MN 55144
Manufacturer Contact
angie draper
3m center, bldg. 275-2w-08
st. paul , MN 55144-1000
(651) 733 -1179
Device Event Key1858273
MDR Report Key1827696
Event Key1730383
Report Number2110898-2010-00103
Device Sequence Number1
Product CodeLBH
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 08/20/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number12145C
Device LOT NumberC90514V
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received08/20/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
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 Invalid Data

-
-