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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 Problems Fever (1858); Pleural Effusion (2010); Decreased Appetite (4569)
Event Date 09/26/2021
Event Type  Injury  
Manufacturer Narrative
Age at time of event: (b)(6) at the time of study enrollment.
 
Event Description
Mandarin study. It was reported that the subject experienced pleural effusion, requiring intervention. On (b)(6) 2021, the subject was enrolled into mandarin study. Planned treatment type was uni-lobar treatment. Treatment with therasphere was performed on the same day. Total calibrated activity prior to infusion was 3. 12 gbq and calculated dose to perfused target liver tissue was 213. 49 gy. On (b)(6) 2021, 2 days post therasphere procedure, the subject experienced loss of appetite and was noted with fever. Both events were considered mild. No action was taken to treat the events. The events were considered resolved within 1-2 days. On (b)(6) 2021, 21 days post therasphere procedure, the subject experienced loss of appetite. No action was taken to treat the event. The event was considered resolved on (b)(6) 2021. On (b)(6) 2021, 36 days post therasphere procedure, the subject experienced pleural effusion. Pleural puncture was performed as an interventional procedure. On (b)(6) 2021 the event was considered resolved.
 
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Brand NameY-90 THERASPHERE (3 GBQ) CANADA COMM
Type of DeviceMICROSPHERES RADIONUCLIDE
Manufacturer (Section D)
BIOCOMPATIBLES UK LIMITED
chapman house farnham bus prk
weydon lane, farnham
surrey GU9 8 QL
UK GU9 8QL
Manufacturer (Section G)
BIOCOMPATIBLES UK LIMITED
chapman house farnham bus prk
weydon lane, farnham
surrey GU9 8 QL
UK GU9 8QL
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13334071
MDR Text Key284300100
Report Number2134265-2022-00442
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2022
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 Received12/29/2021
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: 01/24/2022 Patient Sequence Number: 1
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