MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-10-21 for I-125 SEED * manufactured by *.
[72401]
I-125 seeds with approximate activity of 0. 34mci/seed were assayed incorrectly prior to shipment and were incorrectly labeled as 0. 28-0. 30mci/seed (lot #w71536). Also, label showed assay date of 22 aug 97 and should have been 22 sept 97. Only one seed permanently implanted in pt is confirmed as being at the higher activity. All other seeds from this lot are accounted for.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416947-1997-03870 |
| MDR Report Key | 130007 |
| Report Source | 05 |
| Date Received | 1997-10-21 |
| Date of Report | 1997-10-21 |
| Date of Event | 1997-09-23 |
| Date Mfgr Received | 1997-09-23 |
| Device Manufacturer Date | 1997-09-01 |
| Date Added to Maude | 1997-11-06 |
| 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 SEED |
| Generic Name | * |
| Product Code | IWI |
| Date Received | 1997-10-21 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 127149 |
| Manufacturer | * |
| Manufacturer Address | * * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-10-21 |