MAUDE Adverse Event Report: SANOFI DUPIXENT PEN INJECTOR (2-PKG); INJECTOR, PEN

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous communication from mfr about pt's dupixent.Stated that there is a quality issue with the pen and transferred to cares rep to assist.No notes provided that pt reported defective device.Left message to get more info at time of report.No info available as to what was defective.Unk if pt missed a dose.No adverse event was reported.Unk if product is on hand to return.Reported to (b)(6) by health professional.

• Brand Name: DUPIXENT PEN INJECTOR (2-PKG)
• Type of Device: INJECTOR, PEN
• Manufacturer (Section D): SANOFI
• MDR Report Key: 12276133
• MDR Text Key: 265274855
• Report Number: MW5102987
• 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
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1