BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHISPERJECT

    MDR report key: 19691560 · Received July 5, 2024

    Report

    Report Number
    MW5157088
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    July 2, 2024
    Report Date
    July 2, 2024
    Manufacturer
    MYLAN PHARMACEUTICALS, INC.
    Product Code
    KZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT STATED WHEN SHE USED THE WHISPERJECT, IT DIDN'T WORK, NOTHING HAPPENED, AND IT DID NOT INJECT THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459407 WHISPERJECT INTRODUCER, SYRINGE NEEDLE KZH MYLAN PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female