BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHISPERJECT

    MDR report key: 11817514 · Received May 12, 2021

    Report

    Report Number
    MW5101331
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Report Date
    April 30, 2021
    Manufacturer
    MYLAN PHARMACEUTICALS INC.
    Product Code
    DYB
    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: WHISPERJECT AUTO INJECTOR BUTTON WILL NOT PUSH. NO OTHER DETAILS PROVIDED; DATE OF OCCURRENCE: UNKNOWN; WAS THE PRODUCT TAKEN/ADMINISTERED? NO; UNKNOWN IF PATIENT EXPERIENCED ANY SIDE EFFECTS; CAN MANUFACTURER CALL PATIENT FOR FOLLOW UP? YES; CAN MANUFACTURER ARRANGE FOR PRODUCT PICK UP? YES. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706835 WHISPERJECT INTRODUCER, SYRINGE NEEDLE DYB MYLAN PHARMACEUTICALS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1