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 2019-06-26 for THERASPHERE? 11GBQ manufactured by Biocompatibles Uk Ltd.
| Report Number | 3002124543-2019-00051 |
| MDR Report Key | 8734292 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2019-06-26 |
| Date of Report | 2019-07-25 |
| Date of Event | 2019-04-24 |
| Date Mfgr Received | 2019-07-25 |
| Date Added to Maude | 2019-06-26 |
| 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 | CHAPMAN HOUSE FARNHAM BUSINESS WEYDON LANE |
| Manufacturer City | FARNHAM, SURREY GU9 8QL |
| Manufacturer Country | UK |
| Manufacturer Postal | GU9 8QL |
| Single Use | 0 |
| Remedial Action | PM |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERASPHERE? |
| Generic Name | THERASPHERE? |
| Product Code | NAW |
| Date Received | 2019-06-26 |
| Model Number | 11GBQ |
| Lot Number | 1899285 |
| Device Expiration Date | 2019-07-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOCOMPATIBLES UK LTD |
| Manufacturer Address | CHAPMAN HOUSE FARNHAM BUSINESS WEYDON LANE SURREY, GU9 8QL UK GU9 8QL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2019-06-26 |