MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-09-30 for I-125 SEEDS * manufactured by Nycomed Amersham.
[115771]
A 72 year-old male underwent an i-125 seed implantation. The pt underwent the implantation because of prostate cancer. No other medical history is known. 71 i-125 seeds, model #6711, were implanted on 8/27/98. An x-ray was taken to confirm that the seeds were in place. Upon counting the seeds, it was detemined that there were only 70 seeds at the implantation site. After another x-ray, it was confirmed that the extra seed had migrated to the lung.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2915056-1998-00002 |
| MDR Report Key | 194220 |
| Report Source | 05 |
| Date Received | 1998-09-30 |
| Date of Report | 1998-09-24 |
| Date of Event | 1998-08-27 |
| Date Mfgr Received | 1998-09-03 |
| Date Added to Maude | 1998-10-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | I-125 SEEDS |
| Generic Name | IMPLANTABLE RADIATION SOURCE |
| Product Code | IWI |
| Date Received | 1998-09-30 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | W81766 AND W81871 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 188695 |
| Manufacturer | NYCOMED AMERSHAM |
| Manufacturer Address | 101 CARNEGIE CTR PRINCETON NJ 085409998 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-09-30 |