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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOCOMPATIBLES LTD. Y-90 THERASPHERE (3 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE

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BIOCOMPATIBLES LTD. Y-90 THERASPHERE (3 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Encephalopathy (1833); Fatigue (1849); Fever (1858); Nausea (1970); Vomiting (2144); Ascites (2596); Constipation (3274); Decreased Appetite (4569)
Event Date 03/01/2021
Event Type  Injury  
Manufacturer Narrative
Journal article: canadian journal of gastroenterology and hepatology; volume 2021, article id 9926704, 14 pages; https://doi. Org/10. 1155/2021/9926704. Date of event: the date of event is not specified therefore the date of the article submission was used.
 
Event Description
It was reported via journal article patient complications occurred. This study aims to identify clinical and imaging prognosticators associated with the successful bridging or downstaging to liver transplantation (lt) in patients undergoing yttrium-90 radio embolization (y90-re) for hepatocellular carcinoma (hcc). The y90 therasphere was referenced in the article. Encephalopathy, ascites, fatigue, abdominal pain, nausea, vomiting, anorexia, constipation, and fever were observed post procedure.
 
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Brand NameY-90 THERASPHERE (3 GBQ) CANADA COMM
Type of DeviceMICROSPHERES RADIONUCLIDE
Manufacturer (Section D)
BIOCOMPATIBLES LTD.
chapman house, farnham bus prk
weydon lane
farnham, surrey
UK
Manufacturer (Section G)
BIOCOMPATIBLES UK LIMITED
chapman house farnham bus prk
surrey GU9 8 QL
UK GU9 8QL
Manufacturer Contact
johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13006697
MDR Text Key282272988
Report Number2134265-2021-15780
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/14/2021 Patient Sequence Number: 1
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