MAUDE Adverse Event Report: UNKN HUMIRA PEN STRT CD/UC/HS.; INJECTOR, PEN.

Lot Number	1154587
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The patient states that she was giving herself the first loading dose of the humira from the humira pen starter kit for cd/uc/hs which comes with #380mg/0.8ml pens.She states she was giving herself the injection from the first of 2 pens for her loading dose and that while holding the pen to her skin, never heard any click or felt anything after waiting for at least 15 seconds so pulled the pen away to see if there was something wrong with the pen and when pulling the pen away, the pen released the dose a liquid came out everywhere.No missed dose: no adverse events reported; unknown if device available for return; medical doctor aware.No further information provided.Abbvie.Reported to (b)(6) by : patient/caregiver.

• Brand Name: HUMIRA PEN STRT CD/UC/HS.
• Common Device Name: INJECTOR, PEN.
• Manufacturer (Section D): UNKN
• MDR Report Key: 13771740
• Report Number: MW5108166
• Device Sequence Number: 3892571
• Product Code: NSC
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/01/2023
• Device Lot Number: 1154587
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2022
• Patient Sequence Number: 1
• Patient Sex: Female