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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP BARRX UNKNOWN BEACON

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COVIDIEN LP BARRX UNKNOWN BEACON Back to Search Results
Model Number UNKNOWN BEACON
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Septic Shock (2068); Blood Loss (2597); No Code Available (3191)
Event Date 02/01/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to literature source of study performed (july 2010 to february 2018), to evaluate the safety and infection risk associated with endoscopic ultrasound guided fiducial placement for pancreatobiliary malignancies and used of peri procedural prophylactic antibiotics. 7 patient's developed severe procedural adverse event. Three patients developed acute pancreatitis, one patient had major bleeding requiring blood transfusion after eus-guided fiducial placement, one patient developed acute cholangitis, one patient developed bacteremia and one patient developed septic shock.
 
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Brand NameUNKNOWN BEACON
Manufacturer (Section D)
COVIDIEN LP BARRX
covidien gi solutions
sunnyvale CA 94085 4022
Manufacturer (Section G)
COVIDIEN LP BARRX
covidien gi solutions
sunnyvale CA 94085 4022
Manufacturer Contact
amy beeman
161 cheshire lane, suite 100
plymouth, MN 55441
7632104064
MDR Report Key9857102
MDR Text Key192171054
Report Number3004904811-2020-00003
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 03/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN BEACON
Device Catalogue NumberUNKNOWN BEACON
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 Received03/02/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 03/19/2020 Patient Sequence Number: 1
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