MAUDE Adverse Event Report: INSULIN PEN; INJECTOR, PEN

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A reporter called to report her insulin pen is stuck and she can't push it down to deliver the medication.She said the top won't go down.One of the needles goes down but the other one won't.She said she experienced this problem with 2 out of 4 insulin pens.She also stated, she has been using them for the past ten years and did not experienced this kind of problems before.

• Brand Name: INSULIN PEN
• Type of Device: INJECTOR, PEN
• MDR Report Key: 12325563
• MDR Text Key: 267033626
• Report Number: MW5103270
• Device Sequence Number: 1
• Product Code: NSC
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Weight: 57