MAUDE Adverse Event Report: PEMBROLIZUMAB PORT; SET, ADMINISTRATION INTRAVASCULAR

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).

• Brand Name: PEMBROLIZUMAB PORT
• Type of Device: SET, ADMINISTRATION INTRAVASCULAR
• MDR Report Key: 9480374
• MDR Text Key: 171803444
• Report Number: MW5091702
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/18/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 79