MAUDE MDR 7813060

MDR report key
7813060
Report number
MW5079368
Event key
0
Event type
3
Date of event
2018-08-07
Date received
2018-08-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
306
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
13M VANISH WHITE VARNISH FOR ORTHODONTIC USE 5% SODIUM FLUORIDEVARNISH CAVITY3M ESPE DENTAL PRODUCTSLBHI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-230

Event Narratives#

D

Patient 1

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).