FDA.reportPublic FDA data

MAUDE MDR 3096492

MDR report key
3096492
Report number
1037598-2013-00002
Event key
0
Event type
3
Date of event
2013-01-09
Date received
2013-04-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
BETSY CORTELLONI
Address
5203 BRISTOL INDUSTRIAL WAY BUFORD GA 30518 US
Phone
770-770-7709
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1I-SEEDRADIONUCLIDE BRACHYTHERAPY SOURCETHERAGENICSKXKAGX100NAX12-0676-0692, -0708R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-04-2501. O

Event Narratives#

D

Patient 1

PROCEDURE WAS AN I125 PROSTATE BRACHYTHERAPY IMPLANT. SUBMITTED VIA A VOLUNTARY MEDWATCH REPORT. FACILITY STATES THAT THE INITIAL POST-IMPLANT CT SCAN IDENTIFIED MULTIPLE SEEDS TO HAVE MIGRATED INFERIORILY OUT OF THE PROSTATE, AND INTO THE PENILE BULB. AT THE 6-WEEK POST IMPLANT SCAN, FURTHER MIGRATION FOUND SEEDS LODGED WITHIN THE SHAFT OF THE PENIS WITHIN THE CORPORA SPONGLOSUM. THE MEDWATCH REPORT INDICATED THE PT HAD AGREED WITH RECOMMENDATION FOR SUBSEQUENT IMPLANTATION TO COVER THE UNDER-DOSED AREA, BUT NO FURTHER DETAILS WERE PROVIDED. MFR CONFIRMED PT ID AND VERIFIED SECONDARY IMPLANT OCCURRED (B)(6) 2013 (31 SEEDS AT .209 MCI). NO FURTHER INFORMATION WAS PROVIDED.

N

Patient 1

(B)(4). THE STRANDED SEEDS ARE INTENDED TO PROVIDE RADIATION THERAPY. THE SEED STRANDS ARE MANUALLY APPLIED TO THE TARGET TISSUE BY THE TREATING PHYSICIAN. THERE WAS NO DEVICE MALFUNCTION. VOLUNTARY MEDWATCH REPORT #(B)(4).