BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORA THE COMFORT FIT TAMPON MULTIPACK

    MDR report key: 16453400 · Received February 27, 2023

    Report

    Report Number
    MW5115277
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    February 22, 2023
    Report Date
    February 22, 2023
    Manufacturer
    LYV LIFE INC.
    Product Code
    HEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BOUGHT CORA LIFE ORGANIC TAMPON ONLY TO FIND THAT ONE OF THE TAMPONS WAS TAMPERED WITH WHEN GETTING READY TO INSERT. FOUND WHAT LOOKS LIKE DRIED BLOOD ON THE TAMPON ITSELF. LOOKS LIKE IT MAY HAVE BEEN DRIPPED ONTO THE TAMPON BEFORE BEING PUT INTO THE APPLICATOR. I IMMEDIATELY INFORMED THE MANUFACTURER AND THEY ASKED THAT I SEND THE TAMPON AND THE REMAINING BOX BACK AS WELL AS A REFUND AND A FREE PRODUCT. REASON FOR USE: MENSTRUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946878 CORA THE COMFORT FIT TAMPON MULTIPACK TAMPON, MENSTRUAL, UNSCENTED HEB LYV LIFE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female