MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-11-29 for THERASPHERE NI manufactured by Mds Nordion.
[431223]
In a study under hde protocol of therasphere for treatment of unresectable hcc, the pt experienced a sae in the evening 2005: transient temperature spiked up to 100. 5 f (as per spouse's report) after treatment with therasphere. Per report, fever resolved by morning of the following day with use of medrol dose pack and antibiotics. The case was judged by the clinical site as probably related to the treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8022247-2005-00017 |
| MDR Report Key | 649488 |
| Report Source | 05,06 |
| Date Received | 2005-11-29 |
| Date of Report | 2005-11-02 |
| Date of Event | 2005-09-29 |
| Date Mfgr Received | 2005-11-02 |
| Date Added to Maude | 2005-12-07 |
| 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 WARBICK-CERONE |
| Manufacturer Street | 447 MARCH RD |
| 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 | 2005-11-29 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 638979 |
| Manufacturer | MDS NORDION |
| Manufacturer Address | 447 MARCH RD. OTTAWA, ONTARIO CA K2K 1X8 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2005-11-29 |