BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHISPERJECT

    MDR report key: 11321350 · Received February 11, 2021

    Report

    Report Number
    MW5099354
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    February 1, 2021
    Report Date
    February 8, 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

    PER SPONTANEOUS CALL FROM PATIENT; PATIENT STATED WHEN SHE WENT TO INJECT THE MEDICATION THE INJECTOR WOULD NOT MOVE WHEN SHE PUSHED THE PLUNGER AND PRESSED THE BUTTON (PATIENT HAS WHISPERJECT DEVICE), AND THE MED DID NOT DISPENSE. SHE TRIED AGAIN AND THE MED WOULD STILL NOT DISPENSE AND IT IS NOW JAMMED. PATIENT PROVIDED LOT NUMBER, BUT DID NOT HAVE EXPIRATION DATE. PATIENT DID NOT MISS A DOSE SINCE SHE HAD EXTRA MEDICATION ON HAND. PATIENT DID NOT PROVIDE ANY FURTHER INFORMATION. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214397 WHISPERJECT INTRODUCER, SYRINGE NEEDLE KZH MYLAN PHARMACEUTICALS INC 4013307

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR