MAUDE MDR 6696569

MDR report key
6696569
Report number
MW5070848
Event key
0
Event type
3
Date of event
2016-10-20
Date received
2017-07-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
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-ESPE CLINPRO - WHITE VARNISHCAVITY VARNISH3MLBHI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-0701. S

Event Narratives#

D

Patient 1

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.