FDA.reportPublic FDA data

MAUDE MDR 967133

MDR report key
967133
Report number
1018233-2006-00168
Event key
0
Event type
3
Date received
2006-09-22
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
VIVIAN STEPHENS, MGR
Address
8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BARD BRACHY THERAPY NEEDLEBRACHYTHERAPY NEEDLEC.R. BARD, INC.IWJNA818205UNKNR*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-09-220

Event Narratives#

N

Patient 1

NO SAMPLE WAS RETURNED FOR EVAL AND NO LOT # INFO WAS PROVIDED FOR DEVICE HISTORY REVIEW. A PREVIOUS STUDY FOUND THAT EXCESSIVE FORCE (>6LBS) WAS REQUIRED TO BE APPLIED TO THE CANNULA ABOVE WHAT IS NORMALLY EXPERIENCED (1-2 LBS) IN THE PROCEDURE FOR BREAKAGE TO RESULT. AN ANALYSIS OF THE LABELING FOUND THE FOLLOWING: CAUTION: NEEDLES ARE NOT INTENDED TO PENETRATE BONE. IF RESISTANCE IS ENCOUNTERED, VERIFY NEEDLE POSITION. DO NOT PUSH INTO BONE; THIS MAY CAUSE NEEDLE TO BEND OR BREAK. REPLACE NEEDLE IF CANNULA, OR POINT IS DAMAGED. BASELINE REPORT PREVIOUSLY FILED.