BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O.B. ORIGINAL TAMPONS

    MDR report key: 3595404 · Received January 14, 2014

    Report

    Report Number
    2515444-2014-00001
    Event Type
    Injury
    Date Received
    January 14, 2014
    Date of Event
    January 1, 1991
    Report Date
    October 14, 2014
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    HIL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ENERGIZER PERSONAL CARE, LLC IS SUBMITTING THIS REPORT ONLY BECAUSE AN EVENT MEETING THE REQUIREMENTS OF 21 CFR 803 MAY HAVE OCCURRED. THIS DOES NOT MEAN THAT AN ENERGIZER PRODUCT MALFUNCTIONED OR THAT AN ENERGIZER PRODUCT WAS, IN FACT, ASSOCIATED WITH AN ACTUAL CONSUMER INJURY. CONSEQUENTLY, THE REPORT MUST NOT BE CONSTRUED AS AN ADMISSION OF ANY KIND BY ENERGIZER.

    Description of Event or Problem · 1

    AN O.B. TAMPON USER CALLED TO REPORT SHE WAS DIAGNOSED WITH TSS IN 1991 AND NEVER TREATED. AT THE TIME OF HER DIAGNOSIS SHE WAS USING O.B. TAMPONS. USER STATES SHE HAD NUMEROUS DIAGNOSES AND TREATMENTS FOR VARIOUS AILMENTS OVER THE YEARS AND HAS BEEN DISABLED FOR 14 YEARS. SHE HAS A RASH ON HER FACE, IS LOSING HER HAIR, AND HAS LUNG AND INTESTINAL ISSUES AS WELL AS VAGINAL DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36605 O.B. ORIGINAL TAMPONS O.B. TAMPONS HIL JOHNSON & JOHNSON

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability