FDA.reportPublic FDA data

MAUDE MDR 862669

MDR report key
862669
Report number
3027615-2007-00001
Event key
0
Event type
3
Date of event
2007-04-11
Date received
2007-06-06
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
ANDIE BARTOLET
Address
6575 BUTLER CREEK RD. MISSOULA MT 59808 US
Phone
406-406-4065
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1QUICK TIPEMS: VARIOUS SIZES AND STYLES OF PERIODONTIC INSTRUMENTSAMERICAN EAGLE INSTRUMENTS, INC.EMSBARNHART 5AECB5XPQTHV6NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-06-0601. O

Event Narratives#

D

Patient 1

ADVERSE EVENT - DENTAL INSTRUMENT BROKE OFF DURING PROCEDURE. PT WAS HEALTHY PRIOR TO INCIDENT. PT REQUIRED ADDITIONAL TREATMENT/SURGERY AFTER INCIDENT. APPROX TWO DAYS LATER, THE SURGICAL AREA BECAME INFECTED CAUSING THE PT A LOT OF PAIN AND ADDITIONAL CARE.

N

Patient 1

MICROSCOPIC VISUAL PERFORMED FOR PROCESS DEFAMATION OR METALLURGICAL ANOMALIES - NO ANOMALIES OBSERVED.