MAUDE Adverse Event Report: AMGEN INC. ON-BODY INJECTOR; NEULASTA

Health Effect - Clinical Code	No Information (3190)
Date of Event	08/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Neulasta on body injector fell off of patient at home.Dates of use: (b)(6)2017.Diagnosis or reason for use: drug induced neutropenia.

• Brand Name: ON-BODY INJECTOR
• Common Device Name: NEULASTA
• Manufacturer (Section D): AMGEN INC.
• MDR Report Key: 6839086
• Report Number: MW5071911
• Device Sequence Number: 1121736
• Product Code: NSC
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 74