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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOCOMPATIBLES LTD. Y-90 THERASPHERE (4 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE
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BIOCOMPATIBLES LTD. Y-90 THERASPHERE (4 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE Back to Search Results
Model Number 2361-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Inflammation (1932); Unintended Radiation Exposure (4565)
Event Date 07/01/2021
Event Type  Injury  
Event Description
It was reported that radiation pneumonitis and dyspnea occurred. On (b)(6) 2021, patient underwent a transarterial radioembolization (tare) procedure with therasphere y-90 microspheres. Six dose vials were administered. On (b)(6) 2021, patient presented with dyspnea and a computed tomography scan was performed to reveal radiation pneumonitis. The patient partially improved from radiation pneumonitis after steroid treatment, but dyspnea persisted. No further information is known at this time. This report will be updated should additional information becomes available.
 
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Brand NameY-90 THERASPHERE (4 GBQ) CANADA COMM
Type of DeviceMICROSPHERES RADIONUCLIDE
Manufacturer (Section D)
BIOCOMPATIBLES LTD.
chapman house, farnham bus prk
weydon lane
farnham, surrey
UK
MDR Report Key12668792
MDR Text Key277641254
Report Number2134265-2021-13221
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 company representative,distri
Type of Report Initial
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2361-01
Device Catalogue Number2361-01
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/20/2021 Patient Sequence Number: 1
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