BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHISPERJECT AUTOINJECTOR

    MDR report key: 14576237 · Received June 1, 2022

    Report

    Report Number
    MW5110056
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    May 16, 2022
    Report Date
    May 23, 2022
    Manufacturer
    MYLAN PHARMACEUTICALS INC.
    Product Code
    KZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT REPORTING SHE HAD 4 WASTED DOSES OF GLATIRAMER AND SHE THINKS HER WHISPERJECT AUTO INJECTOR IS FAULTY. PT REPORTS 3 DOSES THE MEDICATION DRIPPED DOWN HER LEG INSTEAD BEING INJECTED [MAY 16,18, 20 2022]. THEN SHE TRIED TO LOAD A SYRINGE IN THE INJECTOR LAST NIGHT MAY22 2022 BUT IT WAS JAMMED AND SHE COULDN'T LOAD IT. PT REPORTS SHE DOES HAVE MEDICATION LEFT, AND SHE WILL TAKE IT TO HER DOCTOR'S OFFICE TODAY TO GET AN INJECTION. NO ADDITIONAL INFORMATION AVAILABLE. UNKNOWN IF PATIENT MISSED A DOSE. UNK IF ADVERSE EVENT OCCURRED. UNKNOWN IF PATIENT CURRENTLY POSSESSES DEFECTIVE DEVICE. UNKNOWN IF SPECIALIST IS YET AWARE. NO FURTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23706 WHISPERJECT AUTOINJECTOR INTRODUCER, SYRINGE NEEDLE KZH MYLAN PHARMACEUTICALS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female GLATIRAMER ACETATE (12X1ML) 40MG/ML