BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHISPERJECT

    MDR report key: 18588897 · Received January 25, 2024

    Report

    Report Number
    MW5150767
    Event Type
    Injury
    Date Received
    January 25, 2024
    Date of Event
    January 20, 2024
    Report Date
    January 22, 2024
    Manufacturer
    MYLAN-VIATRIS/MYLAN PHARMACEUTICALS INC.
    Product Code
    KZH
    UDI-DI
    00400527460
    Adverse Event
    Yes
    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'S WIFE ALVINA STATED SOMETIMES THE WHISPERJECT INJECTION IS VERY SLOW; TAKES LONGER THAN 10 SECONDS TO INJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798982 WHISPERJECT INTRODUCER, SYRINGE NEEDLE KZH MYLAN-VIATRIS/MYLAN PHARMACEUTICALS INC. 2612579 00400527460

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male