BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHISPERJECT

    MDR report key: 11938304 · Received June 3, 2021

    Report

    Report Number
    MW5101696
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 18, 2021
    Report Date
    May 18, 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

    REPORTER OF PRODUCT COMPLAINT: PATIENT; SUMMARY OF PRODUCT COMPLAINT: PATIENT STATED SHE MISSED DOSE LAST NIGHT DUE TO WHISPERJECT DID NOT WORK. UNKNOWN IF PATIENT EXPERIENCED ANY SIDE EFFECTS; DATE OF OCCURRENCE: (B)(6) 2021; WAS THE PRODUCT TAKEN/ADMINISTERED?: NO; CAN MANUFACTURER CALL PATIENT FOR FOLLOW UP?: YES; CAN MANUFACTURER ARRANGE FOR PRODUCT PICK UP? YES; MD NOT AWARE- PATIENT WILL FOLLOW UP WITH MD. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832009 WHISPERJECT INTRODUCER, SYRINGE NEEDLE KZH MYLAN PHARMACEUTICALS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR