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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED Y-90 THERASPHERE (3 GBQ) CANADA COMM; MICROSPHERES RADIONUCLIDE
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BIOCOMPATIBLES UK LIMITED 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 Problem Ascites (2596)
Event Date 06/01/2021
Event Type  Death  
Manufacturer Narrative
Date of event: event date is unknown.Therefore, event date is estimated to the first day of the month the bsc became aware.
 
Event Description
It was reported that ascites and death occurred.The patients sister reported to the customer support mailbox, that the patient developed ascites and passed away post thermosphere implant.No further information is known at this time.This report will be updated should additional information become available.
 
Manufacturer Narrative
E1: update to initial reporter information.Date of event: event date is unknown.Therefore, event date is estimated to the first day of the month the bsc became aware.
 
Event Description
It was reported that ascites and death occurred.The patients sister reported to the customer support mailbox, that the patient developed ascites and passed away post therasphere implant.No further information is known at this time.This report will be updated should additional information become available.
 
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Brand Name
Y-90 THERASPHERE (3 GBQ) CANADA COMM
Type of Device
MICROSPHERES RADIONUCLIDE
Manufacturer (Section D)
BIOCOMPATIBLES UK LIMITED
chapman house farnham bus park
weydon lane
farnham, surrey GU9 8 QL
UK  GU9 8QL
MDR Report Key12149833
MDR Text Key260971325
Report Number2134265-2021-08778
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received07/16/2021
Patient Sequence Number1
Patient Outcome(s) Death;
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