MAUDE Adverse Event Report: SANOFI-AVENTIS U.S. LLC 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 the manufacturer/assistance program to report that they will send a replacement pen due to a malfunction.It is unknown if a dose was missed and no adverse event was reported.It is unknown if defective device is available for manufacturer to pick up.No further information was provided.Specialty has not shipped dupixent yet and must have received from other pharmacy.No more information or dates provided.Reported to (b)(6) by health professional.

• Brand Name: DUPIXENT PEN INJECTOR (2-PKG)
• Type of Device: INJECTOR, PEN
• Manufacturer (Section D): SANOFI-AVENTIS U.S. LLC; 55 corporate dr.; bridgewater NJ 08807
• MDR Report Key: 12525692
• MDR Text Key: 273584037
• Report Number: MW5104184
• 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: 08/25/2021

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
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1