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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 Crack (1135)
Patient Problems Diarrhea (1811); Headache (1880); Dizziness (2194)
Event Type  malfunction  
Event Description
Pt reports with last titration headache, diarrhea, and lightheadedness which resolved after several days. Pt also experienced weight loss since starting veletri and feels she is "too thin. " pt reports that due to weight loss cadd legacy pouch no longer fits her body and she cannot use over the shoulder due to "shoulder issues. " pt reports that in her last shipment of dme, she had a defective invision + connector and tubing set which cracked and had to be swapped out. No other info. Reported (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 Key8527465
MDR Text Key142499042
Report NumberMW5085962
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 04/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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?

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