ENS Event | |
|---|---|
11:00 Jan 11, 2011 | |
| Title | Medical Event - Misadministration of Prostate Cancer Seeds |
| Event Description | During a recent inspection, an NRC inspector noted two cases which occurred on 8/23/11 and 1/11/11, respectively in which two separate patients were under dosed by greater than 20% during prostate cancer treatment using Iodine 125 seeds. The underdose was determined during post operative treatments. The same physician administered the procedure in both cases. The licensee has informed the prescribing physician, and is investigating the cause of the events. There is no long term permanent functional damage suspected to any organ in either case.
The licensee discussed the issue with NRC Region 3 (Gattone).
After the licensee reviewed 3 years of medical reports, fourteen patents were found to have been under-dosed greater than 20% of the prescribed dose. Specific under-dose dates were: 4/10/08; 4/21/08; 4/25/08; 9/15/08; 10/17/08; 11/03/08; 2/17/09; 8/27/09; 1/05/10; 1/14/10; 5/25/10; 10/12/10; 5/03/11 and 5/19/11. The licensee discussed the issue with NRC Region 3 (Gattone). Notified the R3DO (Valos) and the FSME EO (Camper).
The licensee is retracting this event due to the fact that the prostate seed implant for all the above 16 referenced events are planned intra-operatively within the operation. The licensee evaluates the seed implants at the end of the implant operation. Notified the R3DO (Riemer) and FSME (McIntosh). A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. |
| Where | |
|---|---|
| Bay Regional Medical Center Bay City, Michigan (NRC Region 3) | |
| License number: | 21-18585-01 |
| Organization: | Jeppesen Radiation Oncology |
| Reporting | |
| 10 CFR 35.3045(a)(1) | |
| Time - Person (Reporting Time:+6965.43 h290.226 days <br />41.461 weeks <br />9.541 months <br />) | |
| Opened: | Dennis Kehoe 15:26 Oct 28, 2011 |
| NRC Officer: | Joe O'Hara |
| Last Updated: | Dec 1, 2011 |
| 47384 - NRC Website | |
Bay Regional Medical Center with 10 CFR 35.3045(a)(1) | |
WEEKMONTHYEARENS 473842011-01-11T11:00:00011 January 2011 11:00:00
[Table view]10 CFR 35.3045(a)(1) Medical Event - Misadministration of Prostate Cancer Seeds 2011-01-11T11:00:00 | |