MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-03-24 for THERASPHERE 2.79 GBQ N/A manufactured by Biocompatibles Uk Ltd.
| Report Number | 3002124543-2020-00009 |
| MDR Report Key | 9872169 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-20 |
| Date of Event | 2015-07-01 |
| Date Mfgr Received | 2020-03-20 |
| Date Added to Maude | 2020-03-24 |
| 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 | 3 |
| Manufacturer Contact | MS SANDRA BAUSBACK-ABALLO |
| Manufacturer Street | 300 FOUR FALLS CORPORATE CNTR 300 CONSHOHOCKEN STATE ROAD |
| Manufacturer City | WEST CONSHOHOCKEN, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 3311537 |
| Manufacturer G1 | BIOCOMPATIBLES UK |
| Manufacturer Street | CHAPMAN HOUSE WEYDON LANE |
| Manufacturer City | FARNHAM, SURREY |
| Manufacturer Country | UK |
| 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: NAW, PRODUCT |
| Product Code | NAW |
| Date Received | 2020-03-24 |
| Model Number | 2.79 GBQ |
| Catalog Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOCOMPATIBLES UK LTD |
| Manufacturer Address | CHAPMAN HOUSE FARNHAM BUS PARK WEYDON LANE FARNHAM, GU9 8QL UK GU9 8QL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-24 |