MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2019-04-05 for THERASPHERE UNKNOWN N/A manufactured by Biocompatibles Uk Ltd.
[141059641]
The events were reported through a retrospective clinical trial. The events are considered serious and probably related to the therasphere administration. Btg medical assessment: subject (b)(6) is a (b)(6). Ethnicity and medical history not known. Hcc diagnosed (b)(6) 2015, one nodule in segment viii therasphere? Administered (b)(6) 2016, 0. 91 gbq selective administration. Patient had nausea throughout his 6 hour post-procedure observation. Began vomiting towards the end of the scheduled observation. Pt admitted overnight for iv fluids and observation. Able to tolerate po intake overnight. Pt discharged the next day. Recovered without sequelae. Nausea: severity grade 3; serious/expected/related - therasphere. Vomiting:severity grade 3; serious/expected/ related - therasphere (secondary to nausea). No device malfunction was reported and no corrective and preventive action (capa) plan has been identified. The lot number associated with the therasphere administration was not reported, therefore no investigation could be performed. If additional information becomes available, a follow up report will be submitted. No other information is available that could confirm/deny the alleged event. Nausea and vomiting are anticipated adverse events listed in the ifu/risk management documentation. At this time this report is considered final.
Patient Sequence No: 1, Text Type: N, H10
[141059642]
Subject (b)(6) is a (b)(6) male patient enrolled in the (b)(6) study. Hcc diagnosed on (b)(6) 2015, one nodule in segment viii therasphere? Administered (b)(6) 2016, 0. 91 gbq selective administration. Patient had nausea throughout his 6 hour post-procedure observation. Began vomiting towards the end of the scheduled observation. Last episode of vomiting resulted in re-bleeding and hematoma formation at the r cfa access site. Pressure held at access site x 20 min and hemostasis achieved. Pt admitted overnight for iv fluids and observation. Able to tolerate po intake overnight. Pt discharged the next day. The reporter assessed this event as serious as the patient required hospitalization. Nausea and vomiting were assessed as possibly related to therasphere by the physician. The event was not reported to btg by the treating physician at the time of the event in 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002124543-2019-00028 |
| MDR Report Key | 8487131 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2019-04-05 |
| Date of Report | 2019-03-15 |
| Date of Event | 2016-01-26 |
| Date Mfgr Received | 2019-03-15 |
| Date Added to Maude | 2019-04-05 |
| 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 CENTE 300 CONSHOHOCKEN STATE ROAD |
| Manufacturer City | WEST CONSHOHOCKEN, PA 194282998 |
| Manufacturer Country | US |
| Manufacturer Postal | 194282998 |
| Manufacturer Phone | 6103311537 |
| Manufacturer G1 | BIOCOMPATIBLES UK |
| Manufacturer Street | CHAPMAN HOUSE WEYDON LANE |
| Manufacturer City | FARNHAM, SURREY GU9 8QL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | GU9 8QL |
| 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 Code | NAW |
| Date Received | 2019-04-05 |
| Model Number | UNKNOWN |
| Catalog Number | N/A |
| Lot Number | UNKNOWN |
| 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, SURREY GU9 8QL UK GU9 8QL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-04-05 |