BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHISPERJECT

    MDR report key: 13425316 · Received February 1, 2022

    Report

    Report Number
    MW5107143
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Report Date
    January 31, 2022
    Manufacturer
    PHARMACEUTICALS, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHO GAVE YOU INFO? PT. WHAT IS THE COMPLAINT ABOUT THE PRODUCT? NEEDLES ARE SLANTED-UNK IF PT EXPERIENCED ANY SIDE EFFECTS. WAS THE PRODUCT TAKEN OR ADMINISTERED? YES; WHAT IS THE NUMBER? LOT# 210535, EXP: 04/2023. CAN THE MFR CALL THE PT FOR F/U IF NECESSARY? YES. CAN THE MFR ARRANGE FOR PRODUCT PICK UP? NO; MD AWARE AND DRUG THERAPY CONTINUES UNCHANGED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812447 WHISPERJECT INTRODUCER, SYRINGE NEEDLE FMI PHARMACEUTICALS, INC. 210535

    Patients

    Seq Age Sex Outcome Treatment
    1 Female