FDA.reportPublic FDA data

MAUDE MDR 317722

MDR report key
317722
Report number
2916288-2001-00002
Event key
0
Event type
3
Date of event
2001-02-01
Date received
2001-02-21
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
CINDY FEUSTEL
Address
2100 MERIDIAN PARK BLVD CONCORD CA 94520 US
Phone
925-925-9258
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OLSENELECTROSURGICALOLSEN ELECTROSURGICALGEI422-D422030594WBNYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-02-2101. O

Event Narratives#

D

Patient 1

DURING SURGERY TO REMOVE A BREAST MASS, THE PT WAS BURNED ON THE RIGHT AREOLA. THE BURN WAS TREATED WITH AN ANTIBIOTIC OINTMENT. THE BURN WAS CIRCULAR WITH A DIAMETER OF APPROXIMATELY 2MM. THE HOSPITAL FOUND TWO VOIDS IN THE FORCEPS INSULATION, ON THE SAME LEG, 1 3/4 INCHES FROM THE TIPS.