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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 Name
CADD EXT SET
Type of Device
SET, 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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/08/2019
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age62 YR
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