BSD SIGMA 60 APPLICATOR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-03-29 for BSD SIGMA 60 APPLICATOR * manufactured by Bsd Medical Corp.

Event Text Entries

[279909] Pt has locally advanced, radiation and hormone refractory, prostate cancer. They presented with a very large tumor in the prostate that invaded and destroyed the rectum and urinary bladder. Pt had evidence of fistula between the rectum and bladder prior to treatment. Pt was enrolled on protocol # drug 89-002 and treated with re-irridation and hyperthermia which was completed five mos previously. Pt's tumor response was slow and consequent to the tumor-related fistula of the rectum pt underwent a colostomy in 2001, in another state. Pt had been doing well until last week when they informed rptr, on the telephone, of the development of a urinary fistula into the rectum. Pt is enrolled in a gene therapy protocol for refractory prostate cancer and is being followed there. Pt will be undergoing a ureteral hook-up procedure to the colostomy in 2002. Pt's repeat ct scans done have revealed significant tumor shrinkage and pt's serum psa has also decreased from 65 ng/ml prior to treatment to 15 ng/ml at the present time. The development of a fistula in this pt is tumor-related as large prostate tumor had invaded the rectum and urinary bladder prior to therapy. Initially pt developed the fistula due to persistent tumor and tumor destruction of the rectum and bladder. However, now the tumor is showing evidence of shrinkage (ct scan and serum psa response) and this is giving rise to the urinary fistula. Pts with large tumors that invade into adjacent organs, are always at a risk for fistula formation either because of tumor-progression or tumor-shrinkage after effective therapy.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1024576
MDR Report Key386350
Date Received2002-03-29
Date of Report2002-03-29
Date of Event2002-03-21
Date Added to Maude2002-04-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBSD SIGMA 60 APPLICATOR
Generic NameHYPERTHERMIA
Product CodeLNB
Date Received2002-03-29
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key375384
ManufacturerBSD MEDICAL CORP
Manufacturer Address2188 WEST 2200 SOUTH SALT LAKE CITY UT 84119 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2002-03-29

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