FDA.reportPublic FDA data

MAUDE MDR 558793

MDR report key
558793
Report number
1067103-2004-00017
Event key
0
Event type
3
Date received
2004-12-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
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.KXK*102092115YRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-12-0801. R

Event Narratives#

D

Patient 1

PT WAS IMPLANTED WITH DEVICE FILLED TO 4 CC. PT EXPERIENCED SIGNIFICANT EDEMA SURROUNDING THE BALLOON CAUSING A MIDLINE SHIFT AND POSSIBLE HERNIATION TO THE DEVICE. PHYSICIAN DEFLATED BALLOON ON EITHER OF TWO DAYS, ONE DAY OR THE DAY AFTER IN 2004, PHYSICIAN REMOVED THE DEFLATED DEVICE. PT SUFFERED PARALYSIS ON THE RIGHT SIDE DUE TO COMPLICATIONS FROM SURGERY.