BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHISPERJECT DEVICE

    MDR report key: 11669830 · Received April 14, 2021

    Report

    Report Number
    MW5100792
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    April 13, 2021
    Report Date
    April 13, 2021
    Manufacturer
    MYLAN PHARMACEUTICALS INC.
    Product Code
    KZH
    UDI-DI
    00400527460
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT REPORTED TO PHARMACY THAT WHISPERJECT DEVICE NO LONGER WORKS AFTER 2 YEARS. HE REPORTED TO MFR FOR REPLACEMENT AND WAS CALLED BACK TODAY AND TOLD HE HAD TO OBTAIN VIA OPTUM. MISSED 4 DOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560035 WHISPERJECT DEVICE INTRODUCER, SYRINGE NEEDLE KZH MYLAN PHARMACEUTICALS INC. 00400527460

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR