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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (6 GBQ); MICROSPHERES RADIONUCLIDE

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BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (6 GBQ); MICROSPHERES RADIONUCLIDE Back to Search Results
Model Number 2361-03
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chills (2191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/10/2022
Event Type  Injury  
Event Description
It was reported that this patient had prolonged hospitalization for observation post-therapy.This patient was treated with y-90 therasphere therapy around 11am, and for approximately two hours post-procedure the patient experienced rigors (also reported shakes) thought to be due to post-embolization syndrome.The patient was kept overnight in the hospital for observation and was discharged the following day.No further patient complications were reported.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
THERASPHERE Y-90 (6 GBQ)
Type of Device
MICROSPHERES RADIONUCLIDE
Manufacturer (Section D)
BIOCOMPATIBLES UK LIMITED
weydon lane, farnham
surrey GU9 8 QL
UK  GU9 8QL
Manufacturer (Section G)
BIOCOMPATIBLES UK LIMITED
weydon lane, farnham
surrey
UK  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15904368
MDR Text Key304684546
Report Number2124215-2022-47163
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
H980006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 12/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number2361-03
Device Catalogue Number2361-03
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/10/2022
Initial Date FDA Received12/02/2022
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) Hospitalization;
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