FDA.reportPublic FDA data

MAUDE MDR 560202

MDR report key
560202
Report number
1067103-2004-00019
Event key
0
Event type
3
Date of event
2003-11-18
Date received
2004-12-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MARTINE SCHNEIDER
Address
2555 MARCONI DRIVE SUITE 220 ALPHARETTA GA 30005 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GLIASITE RADIATION THERAPY SYSTEM (RTS)BALLOON CATHETER, RADIONUCLIDE APPLICATORPROXIMA THERAPEUTICS, INC.KXK*103077359YRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-12-1501. O

Event Narratives#

D

Patient 1

DEVICE IMPLANTED 2003. BRACHYTHERAPY SUCCESSFULLY DELIVERED WITH A BALLOON INFUSION VOLUME OF 5 CCS 24 DAYS LATER FOR ONE WEEK. IN 2004 PT PRESENTED WITH CEREBRAL EDEMA THAT HAS RESOLVED. THE SITE STATED THAT THE EVENT WAS CONSIDERED POSSIBLY RELATED TO THE DEVICE.