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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PEMBROLIZUMAB PORT SET, ADMINISTRATION INTRAVASCULAR

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PEMBROLIZUMAB PORT SET, ADMINISTRATION INTRAVASCULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Swelling (2091)
Event Date 04/30/2019
Event Type  Injury  
Event Description
Pt reports with rash at port area. Rash began 1 hour after removal of dressing during administration of pembrolizumab. Ed provider thought it might be result of adhesive related to dressing. However pembrolizumab does carry adverse profile for rash. Symptoms: urticaria, pruritus, swelling. Suspect drug #2 dosing: infuse over 30 mins. Treatment drugs used: hydrocortisone (hydrocortisone 0. 1% cream, top), prednisone (prednisone 10mg tab).
 
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Brand NamePEMBROLIZUMAB PORT
Type of DeviceSET, ADMINISTRATION INTRAVASCULAR
MDR Report Key9480374
MDR Text Key171803444
Report NumberMW5091702
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 06/18/2019
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received12/16/2019
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
Is This a Reprocessed and Reused Single-Use Device?

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