FDA.reportPublic FDA data

MAUDE MDR 6331570

MDR report key
6331570
Report number
MW5067899
Event key
0
Event type
3
Date of event
2017-01-11
Date received
2017-02-13
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
1FILLING MATERIAL, TOOTHFILLING MATERIAL, TOOTHUNKEBDI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-02-1301. O; 2. S

Event Narratives#

D

Patient 1

MY WIFE HAS SUFFERED EXTREME PAIN, NAUSEA, VERTIGO AFTER A TOOTH FILLING. THIS HAS HAPPENED TWICE BEFORE AND IN EACH CASE THE TOOTH IN QUESTION HAD TO BE REMOVED WHICH ALLEVIATED THE CONDITION. AFTER MANY MEDICAL VISITS, BLOOD TESTS, URINE SAMPLES ETC, NOTHING HAS BEEN PROVEN AS TO WHICH DRUG IN THE FILLINGS WAS THE CULPRIT. OBVIOUSLY THERE IS A PROBLEM AFFECTING SOME BUT NOT ALL BUT IN HER CASE THIS IS A SERIOUS MATTER AND NEEDS TO BE INVESTIGATED. HER SUFFERING IS HORRENDOUS AND TRYING TO OUTLAST THE REACTION HAS PROVEN TO BE USELESS. HER TOOTH WILL HAVE TO BE REMOVED. THERE IS A CHEMICAL REACTION PROBLEM IN FILLING MATERIALS THAT NO ONE CAN DETERMINE WHICH OF THE MANY CHEMICALS ARE THE CAUSE. THANK YOU. (B)(6). WHY WAS THE PERSON USING THE PRODUCT: FILLING A TOOTH. OTHER SERIOUS/IMPORTANT MEDICAL INCIDENT: KIDNEY PAIN, NAUSEA, VERTIGO. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2017. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT: NO.