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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE ADMINISTRATION SET (B BRAUN)
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BIOCOMPATIBLES UK LTD THERASPHERE ADMINISTRATION SET (B BRAUN) Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Ulcer (2274)
Event Date 12/17/2020
Event Type  Injury  
Event Description
It was reported that a duodenal ulcer occurred. A net metastatic patient was treated with therasphere beads in (b)(6) 2020. In (b)(6) 2020, the patient has developed a duodenal ulcer. Biopsy confirmed the presence of microspheres. The physician noted that the ulcer has persisted and patient is currently scheduled for a surgical consult.
 
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Brand NameTHERASPHERE ADMINISTRATION SET (B BRAUN)
Type of DeviceTHERASPHERE
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
farnham business park
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 Key11165608
MDR Text Key226855004
Report Number3002124543-2021-00002
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
Report Date 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
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 Received12/22/2020
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 Unkown

Patient Treatment Data
Date Received: 01/13/2021 Patient Sequence Number: 1
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