MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2009-05-12 for THERASPHERE manufactured by Mds Nordion.
[1199301]
Literature report of hospitalizations following therasphere treatment in three patients. Event specific info was not available. Publication: reardon et al. Treatment of primary liver tumors with yttrium-90 microspheres (therasphere) in high risk patients: analysis of survival and toxicities. Technology in cancer research and treatment, feb 2009: vol 8(1) ; 71-77. The article reports: "three of the 22 hospitalizations (13. 6%) occurred within one month of the last treatment and were deemed treatment related and were as follows: one patient was admitted with intractable nausea/vomiting and confusion, one pt admitted with abdominal pain, and one pt admitted with a liver abscess. " a discussion of limitations at the end of the article notes that "some of the adverse events reported in this study could be related to an overaggressive technique. "
Patient Sequence No: 1, Text Type: D, B5
[8145818]
Details concerning pt identification, product lot number(s), dates of adminstration, dates of hospitalization or treatment particulars are not available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8022247-2009-00001 |
| MDR Report Key | 1387578 |
| Report Source | 03 |
| Date Received | 2009-05-12 |
| Date of Report | 2009-05-01 |
| Date Mfgr Received | 2009-04-16 |
| Date Added to Maude | 2010-02-02 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 447 MARCH RD. |
| Manufacturer City | OTTAWA, ONTARIO K2K 1X8 |
| Manufacturer Country | CA |
| Manufacturer Postal | K2K 1X8 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERASPHERE |
| Generic Name | YTTRIUM 90 GLASS MICROSPHERES |
| Product Code | IWA |
| Date Received | 2009-05-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDS NORDION |
| Manufacturer Address | 447 MARCH RD. OTTAWA, ON K2K1X8 K2K 1X8 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-05-12 |