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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 Problem Inflammation (1932)
Event Type  Injury  
Event Description
A patient was admitted with pneumonitis after treatment with therasphere on the (b)(6)2020. The patient was treated with 2 therasphere vials, with an absorbed dose of 131gy to the target volume. The absorbed dose to the lungs was 10. 9gy. The reporting physician was not made aware of the date of admission and was solely informed of the patient's hospitalisation. The date range of the pneumonitis presentation and hospitalisation can range from the day of therasphere treatment (b)(6) to the date the reporter and manufacturer became aware (b)(6). The relationship between the pneumonitis and the therasphere treatment was not stated, but is assumed possibly related as the event occured 9 or less days from therasphere treatment.
 
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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 Key10730924
MDR Text Key213035616
Report Number3002124543-2020-00021
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,Followup,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number990700.SPE
Device Lot Number2099433
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 Received11/18/2020
Was Device Evaluated by Manufacturer? No
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: 10/23/2020 Patient Sequence Number: 1
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