FDA.reportPublic FDA data

MAUDE MDR 8577606

MDR report key
8577606
Report number
8010908-2019-00004
Event key
0
Event type
3
Date of event
2019-04-10
Date received
2019-05-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR MICHAEL CYLL
Address
ANTON-FLETTNER-STRASSE 1-3 CUXHAVEN, NIEDERSACHSEN 27472 GM
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VOCO PROFLUORID VARNISHVOCO PROFLUORID VARNISHVOCO GMBHLBHR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-0301. O

Event Narratives#

N

Patient 1

ACCORDING TO OUR RECOMMENDATIONS IN THE INSTRUCTIONS FOR USE, A DOSAGE OF 0.25ML VPV IS UNPROBLEMATIC FOR A COMPLETE SET OF TEETH IN CHILDREN. THE FLUORIDE CONTENT OF A SINGLE DOSE IS WELL BELOW THE PROBABLY TOXIC DOSE OF 5MG PER KG BODY WEIGHT. ACCORDING TO THE DENTIST, ABOUT HALF OF A 0.4 ML SD WAS USED FOR THE TREATMENT. IN OUR EVALUATION, FLUORIDE POISONING CAN BE RULED OUT AT THIS DOSE.

D

Patient 1

A DENTIST RECEIVED A CALL FROM A PARENT ON MONDAY STATING THAT THEIR CHILD HAD FLUORIDE POISONING AFTER HAVING FLUORIDE VARNISH APPLIED TO THEIR TEETH. THE CHILD HAD BEEN SEEN FOR A PROPHYLAXIS APPOINTMENT ON FRIDAY. THE CHILD HAD NAUSEA, SEVERE VOMITING AND FOOT NUMBNESS THAT STARTED FRIDAY AND LASTED OVER THE WEEKEND. THE CHILD WAS SEEN BY THE LOCAL EMERGENCY DEPARTMENT AND BOTH THE EMERGENCY DEPARTMENT AND POISON CONTROL ADVISED THE PARENT THAT THE CHILD'S VOMITING WAS DUE TO ACUTE FLUORIDE POISONING FROM FLUORIDE VARNISH APPLICATION.