FDA Adverse Event
Other
Summary report: N
SIR-SPHERES
MDR report key: 715287
·
Received May 16, 2006
Report
- Report Number
- 9710358-2006-00001
- Event Type
- Other
- Date Received
- May 16, 2006
- Date of Event
- March 28, 2006
- Report Date
- May 11, 2006
- Manufacturer
- SIRTEX MEDICAL LIMITED
- Product Code
- KXK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE PATIENT WAS TREATED WITH SIR-SPHERES FOR COLORECTAL LIVER METASTASES. THE PATIENT WAS TREATED WITH SLR-SPHERES ON TWO SEPERATE OCCASIONS (SEQUENTIAL LOBAR TREATMENT PLAN), OCCURRING IN 2006 AND A MONTH LATER. POST-TREATMENT FOLLOW-UP CT DEMONSTRATED CONTROL OF THE DISEASE IN THE LIVER. THE PATIENT WAS OFF ALL SYSTEMIC CHEMOTHERAPY AT THE TIME OF SLR-SPHERES TREATMENT.PATIENT DEVELOPED ASCITES AFTER SLIR-SPHERES TREATMENT, HOWEVER THE PATIENT'S LIVER FUNCTION TESTS REMAINED STABLE. OTHERWISE THE PATIENT ONLY HAD SOME MILD FATIGUE AFTER TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIR-SPHERES | BRACHYTHERAPY | KXK | SIRTEX MEDICAL LIMITED | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization |