FDA.reportPublic FDA data

MAUDE MDR 612779

MDR report key
612779
Report number
1018233-2005-00040
Event key
0
Event type
3
Date received
2005-06-10
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.IWJNA718205UNKNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-06-1001. O

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT ONE NEEDLE BROKE OFF IN THE PT DURING THE PROCEDURE IN THE OR. THE STAFF WAS ABLE TO GRASP AND REMOVE THE NEEDLE BU HAND AS IT WAS PROTRUDING EXTERNALLY FROM THE PT'S PERINEUM. THE STAFF COULD NOT UNLOAD THE SOURCES DUE TO THE DAMAGED NEEDLE AND THEREFORE WAS UNABLE TO IMPLANT ANY OF THE SEEDS FROM THIS NEEDLE. NO FURTHER COMPLICATIONS WERE REPORTED.