FDA.reportPublic FDA data

MAUDE MDR 604449

MDR report key
604449
Report number
1018233-2005-00029
Event key
0
Event type
3
Date of event
2005-04-07
Date received
2005-05-16
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, MANAGER
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 NEEDLEBRACHYTHERAPY NEEDLEC.R. BARD, INC.IWJNA71820522HO4125NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-05-1601. R

Event Narratives#

D

Patient 1

WHEN USING THE FIRST NEEDLE ON AN IMPLANT CASE, THE DOCTOR PUT THE NEEDLE IN AND HIT BONE. THE NEEDLE BENT SEVERELY AND BROKE OFF STYLET AND ALL IN THE PATIENT WITH NOTHING STICKING OUT. THE DOCTOR MADE A SMALL INCISION IN THE PATIENT'S PERINEUM WITH A SCALPEL AND USED LONG FORCEPS TO GRAB THE NEEDLE AND PUT IT OUT. FOUR RADIOACTIVE PD-103 SEEDS ARE STUCK IN THE NEEDLE WHICH IS IN RADIOACTIVE DECAY STORAGE UNTIL THE SEEDS DECAY TO BACKGROUND. NO FURTHER COMPLICATIONS WERE REPORTED.