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

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.

• Brand Name: 3M ESPE VANISH 5% SODIUM FLUORIDE VARNISH
• Type of Device: VARNISH, 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 Key: 1858273
• MDR Report Key: 1827696
• Event Key: 1730383
• Report Number: 2110898-2010-00103
• Device Sequence Number: 1
• Product Code: LBH
• 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 Received: 09/02/2010
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 12145C
• Device LOT Number: C90514V
• 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 Received: 08/20/2010
• 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