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

Lot Number 1F061A

Device Problems Defective Device (2588); Activation, Positioning or Separation Problem (2906)

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

Event Type  malfunction  

Event Description

Spontaneous call from patient reported had a problem with dupixent when they went to inject the dupixent.They were supposed to hear a click and window didn't tum yellow.Unknown if md is aware no further information provided.Unknown if the dose was missed.Unknown if the defective product on hand for return to the manufacturer.No side effect reported.Frequency: inject 2 pens under the skin on day 1, then inject 1 pen on day 15, then 1 pen every other week thereafter.Reported to (b)(6) by health professional.

• Brand Name: DUPIXENT PEN INJECTOR (2-PKG)
• Type of Device: INJECTOR, PEN
• Manufacturer (Section D): SANOFI US SERVICES INC.
• MDR Report Key: 12682283
• MDR Text Key: 278367842
• Report Number: MW5104886
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2023
• Device Lot Number: 1F061A
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1