FDA.reportPublic FDA data

MAUDE MDR 1340099

MDR report key
1340099
Report number
3004082685-2009-00001
Event key
0
Event type
3
Date received
2009-02-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
STEPHEN SOLOMON
Address
220 SOUTH ORANGE AVE. LIVINGSTON NJ 07039 US
Phone
973-973-9735
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COMPUDENT STAMILESTONE SCIENTIFIC, INC.EJISTA-5110NANAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-02-1901. O

Event Narratives#

D

Patient 1

A COMPUDENT-STA UNIT WAS USED IN CONJUNCTION WITH A WAND-STA HANDPIECE TO PERFORM A DENTAL ANESTHETIC INJECTION. THE DENTIST PERFORMING THE INJECTION REPORTED THAT NECROSIS OF TISSUE OCCURRED AT THE INJECTION SITE. THE DENTIST INJECTED INTO A LOWER MOLAR APPROXIMATELY .9ML OF 4% ARTICANE WITH A 1:100,000 CONCENTRATION OF EPINEPHRINE. THE DOSAGE AND EPINEPHRINE CONCENTRATIONS ADMINISTERED BY THE DENTIST IS SPECIFICALLY NOT RECOMMENDED FOR THESE TYPES OF INJECTIONS IN THE OPERATORS MANUAL.

N

Patient 1

I HAVE ATTACHED A REPORT FROM DR, DIRECTOR OF FROM THE COMPUDENT-STA OPERATORS MANUAL. IN DR'S REPORT, HE OUTLINES HIS CONTACTS WITH THE DENTIST AND HIS CONCLUSIONS. THE DENTIST STATED TO DR THAT SHE DID NOT READ THE INSTRUCTIONS IN THE MANUAL. AN INITIAL EVALUATION WAS CONDUCTED OF THE UNIT INVOLVED IN THIS EVENT. THE RESULTS OF THIS EVALUATION SHOWED THAT THE UNIT WAS OPERATING PER SPECIFICATION. A MORE DETAILED ANALYSIS OF THE UNIT IS UNDERWAY.