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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/12/2021
Event Type  Injury  
Event Description
It was reported that abdominal pain occurred. Patient recieved therasphere treament on (b)(6) 2020. Approximately two weeks after treatment, patient developed intermittent abdominal pain, over the following 7 days pain escalated and patient presented to the emergecy department. A computed tomography scan revealed mild colonic wall thickening in a 2-3 cm segment of colon immediately adjacent to the treatment zone. No signs of leukocytosis, fever, or perforation. There was no extrahepatic deposition of technetium macroaggregated albumin or y90. Pain was controlled with medication and patient was discharged. Of note, the physicain stated it is unclear if this was infectious colitis or reactive given proximity to treatment area. Patient will undergo colonoscopy in 6 weeks to ensure no additional abnormalities are seen.
 
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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 LTD.
chapman house
weydon lane
farnham, GU9 8 QL
UK GU9 8QL
Manufacturer Contact
sandra bausback-aballo
11 hines road
suite 200
ottawa, ontario K2K 2-X1
CA   K2K 2X1
MDR Report Key11311858
MDR Text Key234262268
Report Number3002124543-2021-00003
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
H980006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received01/21/2021
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: 02/10/2021 Patient Sequence Number: 1
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