BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHISPERJECT DEVICE

    MDR report key: 9511216 · Received December 20, 2019

    Report

    Report Number
    MW5091842
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    December 16, 2019
    Report Date
    December 16, 2019
    Manufacturer
    MYLAN PHARMACEUTICALS, INC.
    Product Code
    KZH
    UDI-DI
    00400527460
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT INFORMED US ON (B)(6) 2019 HIS DEVICE IS BROKEN. OBC/FAX MADE TO MDO TO OBTAIN A NEW ONE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294970 WHISPERJECT DEVICE INTRODUCER, SYRINGE NEEDLE KZH MYLAN PHARMACEUTICALS, INC. 00400527460

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR