MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-23 for THERASPHERE manufactured by Mds Nordion.
[4069946]
Subject underwent administration of yttrium y90 for hepatocellular carcinoma on (b)(6) 2013. Subject was admitted after y90 administration for c/o abdominal pain (10 out of 10 on pain scale). Subject was evaluated by ct scan. Findings indicate: no definite findings to explain abdominal pain. Subject was discharged home on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034042 |
| MDR Report Key | 3599465 |
| Date Received | 2014-01-23 |
| Date of Report | 2014-01-21 |
| Date of Event | 2013-08-20 |
| Date Added to Maude | 2014-01-31 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERASPHERE |
| Generic Name | YTTRIUM Y90 BEADS |
| Product Code | IWA |
| Date Received | 2014-01-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDS NORDION |
| Manufacturer Address | OTTAWA ONTARIO K2K1XB CA K2K 1XB |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-01-23 |