• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (4.5 GBQ) CN CLINICAL MICROSPHERES RADIONUCLIDE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (4.5 GBQ) CN CLINICAL MICROSPHERES RADIONUCLIDE Back to Search Results
Model Number 2361-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Low White Blood Cell Count (4433)
Event Date 12/20/2021
Event Type  Injury  
Event Description
(b)(6) study. It was reported decreased lymphocyte count occurred. In (b)(6) 2021 the subject was enrolled into the (b)(6) study. Two weeks later treatment with therasphere was performed; the planned treatment type was selective treatment. Total programmed calculation of dose to perfused target liver tissue was 431. 03 gy. Four days post index procedure, the subject was diagnosed with lymphocyte count decreased with nci-ctcae v5. 0 grade as grade 3 (severe). No action was taken to treat the event. At the time of reporting, the outcome of the event was unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTHERASPHERE Y-90 (4.5 GBQ) CN CLINICAL
Type of DeviceMICROSPHERES RADIONUCLIDE
Manufacturer (Section D)
BIOCOMPATIBLES UK LIMITED
chapman house
weydon lane
surrey GU9 8 QL
UK GU9 8QL
Manufacturer (Section G)
BIOCOMPATIBLES UK LIMITED
chapman house
weydon lane
surrey GU9 8 QL
UK GU9 8QL
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13267273
MDR Text Key283944589
Report Number2134265-2022-00228
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 01/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2022
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/23/2021
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: 01/17/2022 Patient Sequence Number: 1
-
-