MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-05-23 for THERASPHERE * manufactured by Mds Nordian.
[15029303]
Pt with autoimmune hepatitis and hepatocellular cancer who underwent therasphere radioembolization. Shortly after procedure, while in recovery room, pt developed fever and shaking chills. He was transported to the emergency dept for hosp admission and observation. Temp 39. 7, pulse 113, blood pressure 93/39.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035545 |
| MDR Report Key | 752400 |
| Date Received | 2005-05-25 |
| Date of Report | 2005-05-23 |
| Date of Event | 2005-05-11 |
| Date Added to Maude | 2006-08-22 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERASPHERE |
| Generic Name | INSOLUABLE GLASS MICROSPHERES IN WHICH YTTRIUM 90-Y-90 IN AN |
| Product Code | IWA |
| Date Received | 2005-05-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 740200 |
| Manufacturer | MDS NORDIAN |
| Manufacturer Address | * OTTAWA, ONTARIO CA K2K1X8 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2005-05-25 |