MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-05-10 for THERASPHERE NI manufactured by Mds Nordion.
[469878]
Subject was treated with therasphere in 2006. Labs drawn 2 weeks later revealed an elevated bilirubin. Ct on same day revealed radiographic evidence of biliary ductal dilatation due to enlarged tumor. Investigator believes this could be a tumor inflammatory response versus progression of disease and thus indirectly related to therasphere.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8022247-2006-00004 |
| MDR Report Key | 713033 |
| Report Source | 05,06 |
| Date Received | 2006-05-10 |
| Date of Report | 2006-05-09 |
| Date of Event | 2006-05-01 |
| Date Mfgr Received | 2006-05-03 |
| Date Added to Maude | 2006-05-15 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ANN CERONE |
| Manufacturer Street | 447 MARCH ROAD |
| Manufacturer City | OTTAWA, ON K2K 1X8 |
| Manufacturer Country | CA |
| Manufacturer Postal | K2K 1X8 |
| Manufacturer Phone | 5923400 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERASPHERE |
| Generic Name | RADIOACTIVE MICROSPHERES |
| Product Code | IWA |
| Date Received | 2006-05-10 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | 6990014 |
| ID Number | NI |
| Device Expiration Date | 2016-06-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 702095 |
| Manufacturer | MDS NORDION |
| Manufacturer Address | * OTTAWA, ONTARIO CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-05-10 |