BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHISPERJECT AUTOINJECTOR

    MDR report key: 12719479 · Received October 28, 2021

    Report

    Report Number
    MW5105022
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Report Date
    October 26, 2021
    Manufacturer
    MYLAN PHARMACEUTICALS INC.
    Product Code
    KZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL FROM PATIENT WHO REPORTED WHISPERJECT DEVICE JAMMED AND THEY WERE UNABLE TO USE IT UNKNOWN IF THIS CAUSED PATIENT TO MISS DOSE. UNKNOWN IF ANY ADVERSE EVENTS OCCURRED. UNKNOWN IF PATIENT HAD DEFECTIVE DEVICE ON HAND. NO FURTHER INFORMATION. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614331 WHISPERJECT AUTOINJECTOR INTRODUCER, SYRINGE NEEDLE KZH MYLAN PHARMACEUTICALS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1