BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAMPAX PEARL

    MDR report key: 1230104 · Received November 12, 2008

    Report

    Report Number
    MW5008969
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    November 1, 2008
    Report Date
    November 8, 2008
    Manufacturer
    PROCTOR & GAMBLE
    Product Code
    HEB
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2008, WAS THE FIRST TIME I NOTED A PROBLEM WITH THE TAMPAX PEARL TAMPON. WHEN ATTEMPTING TO REMOVE THE TAMPON IT LITERALLY FELL APART INTO SMALL PIECES. THE NEXT DAY, APPROX 15 MINS AFTER INSERTING A TAMPON, I WAS EXPERIENCING SEVERE PAIN & BURNING. I HAD TO REMOVE THE TAMPON WHILE DRIVING. THIS TAMPON ALSO FELL INTO SMALL PIECES- LEAVING A SLEEVE AND SEVERAL SMALL PIECES OF MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAMPAX PEARL TAMPON HEB PROCTOR & GAMBLE 8180243042 09:37

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention