3M-ESPE CLINPRO - WHITE VARNISH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-07 for 3M-ESPE CLINPRO - WHITE VARNISH manufactured by 3m.

Event Text Entries

[79656556] Hyper-salivation handicap resulting from product and/on method of treatment. Hyper-salivation handicap caused as a result of dental treatment with the application of 3m espe white varnish to the teeth and gums. After application of the varnish the dentist gave me a 3m instruction page. I was not to eat or drink anything for 4-6 hours. I carefully followed the instructions. For 6 hours my mouth was completely dry. I was very thirsty. I also did not swallow because of the varnish. Since my varnish application on (b)(6) 2016 i have had an abnormal increase in saliva flow. This has caused me an embarrassing handicap in my work as a teacher and in my social life. When talking it is difficult not to spit into people's faces. I have tried using a medical mask but this is not a good solution. On (b)(6) 2017 i had an examination by an oral surgeon at (b)(6) dental school. The surgeon confirmed the stimulation of saliva overproduction by the glands. Never in my life have i ever had a hypersalivation problem before (b)(6) 2016. I am seeking a cure. I have no objections to medwatch contacting 3m for an opinion.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5070848
• MDR Report Key: 6696569
• Date Received: 2017-07-07
• Date of Report: 2017-06-30
• Date of Event: 2016-10-20
• Date Added to Maude: 2017-07-10
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: 3M-ESPE CLINPRO - WHITE VARNISH
• Generic Name: CAVITY VARNISH
• Product Code: LBH
• Date Received: 2017-07-07
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: 3M

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2017-07-07