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.
[141064365]
The events were reported through a retrospective clinical trial. Btg medical assessment: patient is a subject enrolled in the (b)(6) study: male (b)(6), white, hcc diagnosed (b)(6) 2015 with radiology, one nodule in segment viii, albumin 30g/l, afp 1835 ng/ml, child a6 bclc a. First therasphere? Administration (b)(6) 2015: patient was diagnosed with sepsis (b)(6) 2015 and (approximately 10 days after treatment)approximately 10 days after treatment, he was admitted to an outside hospital in (b)(6) for fatigue, weakness and concern over infection with sirs physiology. He received a course of antibiotics and was discharged with a home nurse as well as occupational therapy. At the follow up visit (b)(6) 2016, hematology tests were within the limits of normal an afp has decrease to 21 ng/ml. Conclusion: syndrome that combines fatigue and fever, in accordance with diagnosis of systemic inflammatory response syndrome (sirs). This is an inflammatory state affecting the whole body in response to an infectious or non infectious insult. Antibiotics were provided, however the occurrence of an infection was not documented, event = sirs + proven of probable infection = sepsis, severity grade 3, serious ae, which lead to hospitalization and medical intervention, anticipated ae, related to therasphere? Administration. 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. Sepsis is an anticipated adverse event as per the ifu/risk management documentation.. At this time this report is considered final.
Patient Sequence No: 1, Text Type: N, H10
[141064366]
Subject (b)(6) is an (b)(6) white male patient enrolled in the (b)(6) study. Medical history of: alcohol abuse; cirrhosis; diabetes; (b)(6); smoker; other - fissure anal; barret oesophagus; meningitis; arthritis. Hcc diagnosed on (b)(6) 2015, one nodule in segment viii, therasphere? Administered (b)(6) 2015, total administered activity gbq 1. 8572, lung shunt fraction 7. 54%. Patient was diagnosed with sepsis (b)(6) 2015 and (approximately 10 days after treatment) patient was admitted to an outside hospital in for fatigue, weakness and concern over infection with sirs physiology. He received a course of antibiotics and was discharged with a home nurse as well as occupational therapy. He tells me that he suffered severe fatigue, which has improved but certainly not resolved by today. Patient was discharged (b)(6) 2015. Outcome: resolved. The events were not reported to btg by the investigator in 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002124543-2019-00031 |
| MDR Report Key | 8487620 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2019-04-05 |
| Date of Report | 2019-03-29 |
| Date of Event | 2015-12-21 |
| Date Mfgr Received | 2019-03-29 |
| 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; 2. Required No Informationntervention | 2019-04-05 |