FDA.reportPublic FDA data

MAUDE MDR 558528

MDR report key
558528
Report number
1067103-2004-00015
Event key
0
Event type
3
Date of event
2004-11-06
Date received
2004-12-07
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#

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)MANUAL RADIONUCLIDE APPLICATOR SYSTEMPROXIMA THERAPEUTICS, INC.IWJ*1020UNKNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-12-0701. O; 2. R

Event Narratives#

D

Patient 1

RETRIEVAL OF IOTREX WAS SCHEDULED FOR 6:25PM 11/2004. IOTREX WAS REMOVED AT 11:00AM THE NEXT DAY PATIENT RECEIVED 74 GY AT 0.5 CM RATHER THAN THE PRESCRIBED DOSE OF 60 GY AT 0.5CM. THIS OCCURRED BECAUSE OF AN OVERSIGHT BY THE RADIATION ONCOLOGIST.