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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE YTTRIUM-90 GLASS MICROSPHERES

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BIOCOMPATIBLES UK LTD THERASPHERE YTTRIUM-90 GLASS MICROSPHERES Back to Search Results
Model Number 990700.SPE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Cognitive Changes (2551)
Event Date 07/26/2020
Event Type  Injury  
Event Description
Patient (b)(6) with a hcc tumour in segment viii of the right liver was enrolled in the (b)(6) registry study on (b)(6) 2020. The patient received therasphere administration on the same day to the right liver. The perfused liver volume and absorbed dose has not been reported. On (b)(6) 2020 (45 days post therasphere administration), the patient presented with fever (38. 2 c), abdominal pain and cognitive disturbance. The patient was hospitalized for further evaluation and treatment, and was treated with antibiotics and surgical intervention. The patient also presented in (b)(6) 2020 with anorexia (grade 3), which was also assessed to be related to therasphere procedure, but no action was taken to resolve the anorexia. The physician assessed the abdominal pain and cognitive disturbance as a grade 2 serious adverse event (as defined in the ctcae v5. 0 adverse event reporting guideline, and as probably related to the therasphere administration procedure.
 
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Brand NameTHERASPHERE
Type of DeviceYTTRIUM-90 GLASS MICROSPHERES
Manufacturer (Section D)
BIOCOMPATIBLES UK LTD
chapman house farnham bus park
weydon lane
farnham, GU9 8 QL
UK GU9 8QL
Manufacturer (Section G)
BIOCOMPATIBLES UK
chapman house
weydon lane
farnham, GU9 8 QL
UK GU9 8QL
Manufacturer Contact
sandra bausback-aballo
300 four falls corporate cente
300 conshohocken state road
west conshohocken, PA 19428-2998
6103311537
MDR Report Key10659499
MDR Text Key216395785
Report Number3002124543-2020-00018
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
H980006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number990700.SPE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2020
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/09/2020 Patient Sequence Number: 1
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