BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHISPERJECT

    MDR report key: 11648035 · Received April 9, 2021

    Report

    Report Number
    MW5100681
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    April 7, 2021
    Report Date
    April 7, 2021
    Manufacturer
    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

    Narratives

    Description of Event or Problem · 1

    PATIENT STATED THE WHISPERJECT WOULDN'T FIRE AND NOW THE BUTTON IS STUCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541546 WHISPERJECT INTRODUCER, SYRINGE NEEDLE KZH MYLAN PHARMACEUTICALS INC 00400527460

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR