3M VANISH WHITE VARNISH FOR ORTHODONTIC USE 5% SODIUM FLUORIDE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-23 for 3M VANISH WHITE VARNISH FOR ORTHODONTIC USE 5% SODIUM FLUORIDE manufactured by 3m Espe Dental Products.

Event Text Entries

[118393789] He had a dental varnish applied after a cleaning. A few hours latter, he suddenly had a terrible pain in his stomach, he was crying, rolling on the floor and then threw up. My (b)(6) y/o son had a varnish applied to his teeth on (b)(6) 2018. A few hours later he was on the floor, rolling around in agony. I thought it might be appendicitis he was in such pain. He then got up feeling nauseous and threw up. The only thing out of the ordinary was the varnish. He waited a few hours after the treatment to eat and drink. I think it was the fluoride he had a reaction to. When i contacted 3m, they would not disclose all the ingredients which i think i have a right to know. My son is on no medications nor does he use any medical devices, and took no vitamins, minerals or herbal supplements that day. He odd time i give my son a fish oil supplement and a multi-vitamin gummy. I think it's wrong that i cannot have the ingredients to something that concerns my son. From my research this product is considered a drug and when i looked at overdose of fluoride symptoms, my son's symptoms were the same. I feel so strongly i have to send this. I was told this is classified as a device although it has fluoride which is a drug. My son had major abdominal discomfort and vomiting. Thank you for your time, (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5079368
MDR Report Key7813060
Date Received2018-08-23
Date of Report2018-08-13
Date of Event2018-08-07
Date Added to Maude2018-08-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand Name3M VANISH WHITE VARNISH FOR ORTHODONTIC USE 5% SODIUM FLUORIDE
Generic NameVARNISH CAVITY
Product CodeLBH
Date Received2018-08-23
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
Manufacturer3M ESPE DENTAL PRODUCTS


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-23

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