BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHISPERJECT

    MDR report key: 12446205 · Received September 8, 2021

    Report

    Report Number
    MW5103778
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    June 7, 2021
    Report Date
    June 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

    SPONTANEOUS FROM (B)(6) NURSE AT MANUFACTURER MEDICAL INFORMATION CENTER, WHO REPORTED A SYRINGE MALFUNCTION THAT OCCURRED ON (B)(6) 2021, BUT THE DETAILS OF EVENT WERE NOT REPORTED. PATIENT DID MISS A DOSE AS A RESULT OF THE MALFUNCTION, BUT NO SIDE EFFECTS AS A RESULT OF THE MISSED DOSE. DEVICE IS NO LONGER STILL ON HAND FOR RETURN, BUT LOT NUMBER AND EXPIRATION DATE WERE REPORTED. NO FURTHER INFORMATION. PATIENT ALSO STATED THAT ONE PEN HAD A CROOKED TIP, SHE IS IN CONTACT WITH DUPIXENT MANUFACTURER FOR A REPLACEMENT. THERE WAS NO MISSED DOSE OR ADVERSE EVENT AS A RESULT OF THE DEFECTIVE PRODUCT. NO OTHER INFORMATION KNOWN. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339890 WHISPERJECT INTRODUCER, SYRINGE NEEDLE KZH MYLAN PHARMACEUTICALS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR