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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 Liver Damage/Dysfunction (1954); Ascites (2596); Swelling/ Edema (4577)
Event Date 08/14/2019
Event Type  Injury  
Event Description
It was reported that edema-ascitic decompensation occurred.On (b)(6) 2019, the patient was enrolled into the proactif study and the treatment with therasphere was performed on the same day.Advanced, multicompartment dosimetry was performed to assess treatment dose.0.49 gbq was administered to the liver (right liver) through vial 1 and 2.97 gbq was administered to the liver (selective) through vial 2.On (b)(6) 2019, 50 days after the index procedure, patient developed edema-ascitic decompensation and was hospitalized for further evaluation and treatment.The patient was noted to have edema from lower limbs to the knee, weight gain and increase in abdomen size.The event was treated medically and considered resolved.
 
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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 Key12137510
MDR Text Key260572983
Report Number2134265-2021-08625
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 07/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
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 Received06/16/2021
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 Age84 YR
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