FDA.reportPublic FDA data

MAUDE MDR 284989

MDR report key
284989
Report number
1018233-2000-00021
Event key
0
Event type
3
Date received
2000-07-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
VIVIAN STEPHENS
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 BRACHYTHERAPY NEEDLESEED IMPLANT NEEDLEC.R. BARD, INC.IWJNA618201UNKNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12000-07-0701. R

Event Narratives#

D

Patient 1

UROLOGIST ATTEMPTED TO PLACE NEEDLE AND HIT BONE. HE CONTINUED TO ADVANCE NEEDLE WHICH THEN BROKE. ONE REPORT STATED RETAINED PIECE WAS VERIFIED BY X-RAY TO BE IN PROSTATE; SECOND REPORT STATED RETAINED PIECE WAS LODGED IN FATTY TISSUE OF BUTTOCKS. RETAINED PIECE WILL BE REMOVED IN 60 DAYS OR ONE/HALF LIFE SPAN OF IODINE SEEDS WHICH REMAINED IN NEEDLE.