FDA.reportPublic FDA data

MAUDE MDR 295744

MDR report key
295744
Report number
MW1019888
Event key
0
Event type
3
Date of event
2000-03-27
Date received
2000-09-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NANAUNKEKKUNKUNKUNKN*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12000-09-0501. S

Event Narratives#

D

Patient 1

BEGAN EXPERIENCING NUMBNESS AND PAIN BELOW A TOOTH IN WHICH RPTR HAD A ROOT CANAL DONE IN A NUMBER OF YEARS AGO. THE NUMBNESS RADIATED OUT TO COMPLETE JAW AREA, LIPS, AND TONGUE. AN ENDODONTIST ATTEMPTED A RETREATMENT OF THE TOOTH WHICH WAS UNSUCCESSFUL AND TOOTH WAS EXTRACTED. NUMBNESS INCREASED TO JAW AREAS. NUMBNESS STILL PERSISTS AFTER 5 MONTHS. THIS WRITER FEELS UNSAFE ENDODONTIC MATERIALS WERE USED AND THESE MATERIALS LEECHED INTO BLOOD STREAM AFTER TOOTH DETERIORATED CAUSING PARETHESIA AND PAIN.