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

Lot Number	1F061A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem 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)
• Common Device Name: INJECTOR, PEN
• MDR Report Key: 12682283
• Report Number: MW5104886
• Device Sequence Number: 4612207
• Product Code: NSC
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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
• Operator of Device: No Information
• Device Expiration Date: 06/30/2023
• Device Lot Number: 1F061A
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): No Information
• Usage of Device: N
• Patient Sequence Number: 1