BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHISPERJECT AUTOINJECTOR

    MDR report key: 8922796 · Received August 21, 2019

    Report

    Report Number
    MW5089250
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    August 8, 2019
    Report Date
    August 8, 2019
    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 PT - SHE REPORTED THAT HER GLATIRAMER AND WHISPERJECT DEVICE MALFUNCTIONED. THE BUTTON WOULD NOT PRESS ON THE WHISPERJECT AND THE MEDICATION SPILLED EVERYWHERE. THE PT SAID HE WAS HAVING TROUBLES WITH THE DEVICE, SO WE ARE SENDING A NEW ONE TO HER. THE PT WILL NOT MISS A DOSE SINCE SHE HAS ANOTHER SYRINGE. PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. PT HAD PRODUCT ON HAND DURING REPORT ON 08/08. NO FURTHER INFO PROVIDED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712714 WHISPERJECT AUTOINJECTOR INTRODUCER, SYRINGE NEEDLE KZH MYLAN PHARMACEUTICALS INC. 190217

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR