FDA.reportPublic FDA data

MAUDE MDR 448550

MDR report key
448550
Report number
1062385-2003-00005
Event key
0
Event type
3
Date of event
2003-02-20
Date received
2003-03-11
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
ADAM LOWE, VP
Address
3890 STEVE REYNOLDS BLVD NORCROSS GA 30093 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
15F ALPHA IV REV 2 40MM ACTIVE TRANSFER DEVICETRANSFER DEVICENOVOSTE CORP.MOUA1733TDA-0040NAP0000NYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-03-110

Event Narratives#

D

Patient 1

COMPLAINANT REPORTED THAT AFTER THE VBT PROCEDURE, THE CATHETER WAS DISCONNECTED AND DISCARDED. AT THAT TIME, THE DOSE CALIBRATION WAS DONE AND A SIGNIFICANT DECREASE WAS NOTICED. THE SOURCES WERE NO LONGER CONTAINED WITHIN A CLOSED SYSTEM. ONE RADIOACTIVE SEED WAS FOUND ON THE FLOOR AND THE OTHERS WERE FOUND IN THE BAIL OUT BOX. ALL RADIOACTIVE SOURCES WERE POSITIVELY ACCOUNTED FOR AND PLACED IN THE SEED CUP CONTAINER. NO ADVERSE PATIENT OR USER EVENT WAS REPORTED.