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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED Y-90 THERASPHERE (19 GBQ) CANADA COMM; MICROSPHERES RADIONUCLIDE
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BIOCOMPATIBLES UK LIMITED Y-90 THERASPHERE (19 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 06/12/2021
Event Type  Injury  
Event Description
It was reported that radiation pneumonitis and dyspnea occurred.On (b)(6) 2020, patient underwent a transarterial radioembolization (tare) procedure with therasphere y-90 microspheres.Nine 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 Name
Y-90 THERASPHERE (19 GBQ) CANADA COMM
Type of Device
MICROSPHERES RADIONUCLIDE
Manufacturer (Section D)
BIOCOMPATIBLES UK LIMITED
chapman house farnham bus prk
weydon lane, farnham
surrey
UK 
MDR Report Key12661451
MDR Text Key277361537
Report Number2134265-2021-13112
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,foreig
Type of Report Initial
Report Date 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number2361-01
Device Catalogue Number2361-01
Was Device Available for Evaluation? No
Date Manufacturer Received10/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
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