MAUDE Adverse Event Report: HUMIRA PEN (2/BOX); INJECTOR, PEN

Lot Number 1158135

Device Problems Mechanical Problem (1384); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Patient reporting possible defective device.When patient injected, he did not feel the needle pricking, and did not feel the liquid going in, no bleeding.No needle mark.Patient thinks he did not get any of the dose from that pen.Md not aware yet.No further information provided.Advised patient to reach out to abbvie for replacement.Unknown if patient has device on hand for return if needed.Reported to (b)(6)/caremark by pt/caregiver.

• Brand Name: HUMIRA PEN (2/BOX)
• Type of Device: INJECTOR, PEN
• MDR Report Key: 13929567
• MDR Text Key: 288173969
• Report Number: MW5108551
• Device Sequence Number: 1
• Product Code: NSC
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 07/30/2023
• Device Lot Number: 1158135
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male