BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHISPERJECT AUTOINJECTOR

    MDR report key: 11669731 · Received April 14, 2021

    Report

    Report Number
    MW5100788
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Report Date
    April 12, 2021
    Manufacturer
    MYLAN PHARMACEUTICALS INC.
    Product Code
    KZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS. PATIENT REPORTED THAT HER WHISPERJECT WOULD NOT SET PROPERLY, AND SHE WAS UNABLE TO USE IT. SHE HAD TO GIVE HERSELF THE INJECTION UTILIZING THE SYRINGE. THERE IS NO DOSING INFORMATION AS THIS IS A SUPPLY. PATIENT INJECTS MEDICATION WITH SUPPLY AS FOLLOWS: UNKNOWN IF PATIENT HAS AUTOINJECTOR FOR RETURN. NO ASSOCIATED ADVERSE EVENTS REPORTED WITH DEFECTIVE DEVICE. UNSPECIFIED IF DEFECT IS RELATED TO EXPIRATION DATE. PRODUCT LOT NUMBER IS UNKNOWN. THERE WAS NO FURTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560024 WHISPERJECT AUTOINJECTOR INTRODUCER, SYRINGE NEEDLE KZH MYLAN PHARMACEUTICALS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1