MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2000-06-23 for IODINE I125 SEEDS * manufactured by Nycomed Amersham Imaging.
[20683392]
In 1999, a pt rec'd an i-125 seed implant of 109 seeds. Pt contacted medical affairs department on 21 june 2000, saying that since the implant, pt has experienced burning with urination and impotence. When asked for the physician's name, pt did not want to give that info. No further info is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2915056-2000-00001 |
| MDR Report Key | 283708 |
| Report Source | 04 |
| Date Received | 2000-06-23 |
| Date of Report | 2000-06-22 |
| Date of Event | 1999-12-01 |
| Date Mfgr Received | 2000-06-21 |
| Date Added to Maude | 2000-06-30 |
| 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 |
| Manufacturer Street | 101 CARNEGIE CENTER |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IODINE I125 SEEDS |
| Generic Name | * |
| Product Code | IWI |
| Date Received | 2000-06-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 274544 |
| Manufacturer | NYCOMED AMERSHAM IMAGING |
| Manufacturer Address | 3350 NORTH RIDGE AVE ARLINGTON HEIGHTS IL 60004 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-06-23 |