BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORA TAMPON

    MDR report key: 16584204 · Received March 20, 2023

    Report

    Report Number
    MW5115884
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    March 13, 2023
    Report Date
    March 17, 2023
    Manufacturer
    LYV LIFE INC.
    Product Code
    HEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USED A SUPER PLUS TAMPON FROM THE COMPANY CORA AND HAD SEVERE CRAMPING THAT FELT LIKE I WAS BEING STABBED. IT WAS EXCRUCIATING. I HAVE WORN TAMPONS FOR YEARS AND HAVE NEVER HAD A TAMPON AFFECT ME LIKE THAT. CORA TAMPONS SAID THEY WERE 100% COTTON AND DIDN'T HAVE ANYTHING BAD IN THEM BUT THE PRODUCT MUST BE CONTAMINATED, FAULTY, OR MISLEADING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999328 CORA TAMPON TAMPON, MENSTRUAL, UNSCENTED HEB LYV LIFE INC. SUPER PLUS 2012.45.10

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female