BEUDAMED
    FDA Adverse Event Other Summary report: N

    TAMPAX COMPAK TAMPON, REGULAR UNSCENTED

    MDR report key: 3213401 · Received June 14, 2013

    Report

    Report Number
    1219109-2013-00006
    Event Type
    Other
    Date Received
    June 14, 2013
    Report Date
    May 15, 2013
    Manufacturer
    HYGINETT HUNGARIAN AMERICAN CO
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER WAS PROVIDED (220720808901) AND NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THE LOT NUMBER PROVIDED. PRODUCT REQUESTED FROM CONSUMER; PENDING PRODUCT INVESTIGATION UPON RETURN OF PRODUCT.

    Description of Event or Problem · 1

    ARTERIAL BLEEDING; HEAVY BLEEDING FROM INJURED ARTERY - VAGINA [VAGINAL HAEMORRHAGE]. INJURY - VAGINAL [VULVOVAGINAL INJURY]. TAMPAX TAMPON APPLICATOR SPLIT WHEN INSERTED [DEVICE PHYSICAL PROPERTY ISSUE]. CASE DESCRIPTION: A JOURNALIST REPORTED IN AN ARTICLE, DATED MAY 15, 2013, THAT A (B)(6) GIRL WAS GIVEN A PACKAGE CONTAINING TAMPAX COMPAK REGULAR UNSCENTED TAMPONS AT HER SCHOOL. THE GIRL USED THE TAMPON, DURING HER TIME OF THE MONTH, AND HAD ARTERIAL BLEEDING WHEN THE APPLICATOR SPLIT UPON INSERTION. HER MOTHER TOOK HER TO THE HOSPITAL WHERE SHE REQUIRED AN OPERATION FOR HEAVY BLEEDING FROM AN INJURED ARTERY. THE CASE OUTCOME WAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED. (B)(6) 2013: LOT CHECK. LOT NUMBER WAS PROVIDED BY THE CONSUMER. NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THE LOT NUMBER PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272164 TAMPAX COMPAK TAMPON, REGULAR UNSCENTED NONE HEB HYGINETT HUNGARIAN AMERICAN CO 220720808901

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other