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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXT SET SET, ADMINISTRATION INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD EXT SET SET, ADMINISTRATION INTRAVASCULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); High Blood Pressure/ Hypertension (1908)
Event Date 09/10/2019
Event Type  Death  
Event Description
Pt passed away on (b)(6) 2019 due to illness worsening. Indication: primary pulmonary hypertension. Reported to (b)(6) by pt/caregiver.
 
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Brand NameCADD EXT SET
Type of DeviceSET, ADMINISTRATION INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key9310465
MDR Text Key166143915
Report NumberMW5090987
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 11/08/2019 Patient Sequence Number: 1
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