MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-12-03 for RADIO ACTIVE SEEDS manufactured by Theragenics Corp.
[1027729]
Had burning after seed. Implants - had 4 turp surgeries: 10 hr bladder surg, 2 heart attacks c put in stent 2nd attack. Had several bladder blockages. At least ii trips to er. Had several bladder infections. Papers do not have all my doctor visits and test. See scanned pages. Dose or amount: put in by dr masek. Dates of use: 2002 included. Diagnosis or reason for use: prostate cancer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5009145 |
| MDR Report Key | 1260623 |
| Date Received | 2008-12-03 |
| Date Added to Maude | 2009-01-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIO ACTIVE SEEDS |
| Generic Name | FOR PROSTATE CANCER |
| Product Code | IWG |
| Date Received | 2008-12-03 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERAGENICS CORP |
| Manufacturer Address | 5203 BRISTOL INDUSTRIAL WAY BUFORD GA 30518 US 30518 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2008-12-03 |