BEUDAMED
    FDA Adverse Event Other Summary report: N

    TAMPAX TAMPON, PEARL, PLASTIC, REG, UNSCENTED

    MDR report key: 1047994 · Received May 15, 2008

    Report

    Report Number
    1219109-2008-00002
    Event Type
    Other
    Date Received
    May 15, 2008
    Report Date
    May 14, 2008
    Manufacturer
    TAMBRANDS MANUFACTURING, INC.
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED.

    Description of Event or Problem · 1

    A FEMALE PATIENT HAD A TAMPON IN AND COULD NOT GET IT OUT. MOTHER TOOK HER TO THE DOCTOR. DAUGHTER HAD TO HAVE HYMEN CUT. HYMEN SKIN WAS WRAPPED AROUND THE TAMPON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAMPAX TAMPON, PEARL, PLASTIC, REG, UNSCENTED MENSTRUAL TAMPONS, UNSCENTED HEB TAMBRANDS MANUFACTURING, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention