BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUPIXENT PEN INJECTOR (2-PKG)

    MDR report key: 12814512 · Received November 12, 2021

    Report

    Report Number
    MW5105319
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Report Date
    November 9, 2021
    Manufacturer
    SANOFI-AVENTIS U.S. LLC.
    Product Code
    NSC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT REPORTED A BROKEN PEN. IT WAS UNSPECIFIED WHAT THE DETAILS WERE REGARDING THE DEFECT. IT IS UNKNOWN IF THE PATIENT MISSED A DOSE OR EXPERIENCED AN ADVERSE EVENT. IT IS UNKNOWN IF THE DEFECTIVE PRODUCT IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED. IT IS UNKNOWN IF THE MD IS AWARE. REPORTED TO CVS/CAREMARK BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699849 DUPIXENT PEN INJECTOR (2-PKG) INJECTOR, PEN NSC SANOFI-AVENTIS U.S. LLC. 1F065A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female