BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHISPERJECT AUTOINJECTOR

    MDR report key: 12869058 · Received November 23, 2021

    Report

    Report Number
    MW5105560
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Report Date
    November 19, 2021
    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

    (B)(6) PT REGARDING USING HER WHISPERJECT AUTOINJECTOR DEVICE. PT STATES IT HAS MISFIRED A FEW TIMES BEFORE AND NOW IT'S GETTING MUCH WORSE. PT STATES SHE ATTEMPTING TO OPEN INJECTOR AND REPAIR IT BUT NOTICED A LOT OF MEDICATION INSIDE THE AUTOINJECTOR. PT STATES AUTOINJECTOR IS NOT FUNCTIONING AT ALL AT THIS POINT AND PT IS REQUESTING A REPLACEMENT WHISPERJECT DEVICE. PT STATES THIS HAS BEEN GOING ON FOR MORE THAN 6 MONTHS, AND SHE HAS BEEN MISSING DOSES AND NOT CONSISTENTLY TAKING MEDICATION. NO ADE REPORTED; UNKNOWN IF AVAILABLE FOR RETURN; UNKNOWN LOT/EXPIRATION. UNKNOWN IF MD AWARE. NO FURTHER INFORMATION KNOWN. DEVICE USED TO INJECT GLATIRAMER AT ABOVE DOSE AND FREQUENCY. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763271 WHISPERJECT AUTOINJECTOR INTRODUCER, SYRINGE NEEDLE KZH MYLAN PHARMACEUTICALS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female