MAUDE MDR 7512257

MDR report key
7512257
Report number
1941138-2018-00001
Event key
0
Event type
3
Date of event
2018-04-25
Date received
2018-05-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
102
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. JOSE ESPINO
Address
13705 SHORELINE COURT EAST EARTH CITY MO 63045 US
Phone
314-314-3143
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VARNISH PEN - ASSORTEDVARNISHYOUNG DENTAL MANUFACTURING I, LLCLBH295782R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-1401. O

Event Narratives#

D

Patient 1

A PATIENT RETURNED FOR A FOLLOW UP APPOINTMENT AFTER HER HYGIENE APPOINTMENT A WEEK BEFORE. FOLLOWING THE APPOINTMENT, SHE BROKE OUT IN SORES ON THE INSIDE OF HER LIPS AND THINKS IT IS DUE TO THE VARNISH PEN. SHE HASN'T HAD VARNISH USED FOR OVER 2 YEARS AND HAS A KNOWN HISTORY OF LATEX/RUBBER ALLERGY. THE VARNISH PEN WAS USED ON HER, WHICH WAS THE ONLY NEW THING USED. ALL OTHER PRODUCTS USED HAVE BEEN USED ON HER BEFORE. THE PATIENT IS FEMALE IN HER (B)(6) AND HAS BEEN TAKING BENADRYL TO TREAT THE SORES. THE SORES WERE STILL PRESENT DURING THE FOLLOW UP APPOINTMENT. THE VARNISH PEN IS COMPRISED OF VARNISH, AN ALUMINUM TUBE, AND PLASTIC. THERE IS NO KNOWN PRESENCE OF LATEX IN THE MAKEUP OF THESE PARTS. THERE IS NO EVIDENCE THAT SUGGESTS THE POSSIBLE REACTION WAS DUE TO THE VARNISH PEN. BENADRYL WAS USED TO REDUCE THE EFFECTS OF THE POSSIBLE ALLERGIC REACTION THAT OCCURED AFTER THE HYGIENE APPOINTMENT. IT HAS NOT BEEN CONCLUDED THAT IMPAIRMENT OR PERMANENT DAMAGE COULD HAVE OCCURRED IF MEDICATION HAD NOT BEEN USED. HOWEVER, SINCE AN ADDITIONAL PRECAUTION WAS USED, WE BELIEVE THE EVENT IS REPORTABLE. THIS EVENT DID NOT RESULT IN SERIOUS INJURY TO THE PATIENT.