BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPAXTAMPONSPEARLFULLSIZESUPERPLUSUNSCNT18CT

    MDR report key: 21111499 · Received January 9, 2025

    Report

    Report Number
    1219109-2025-00008
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Report Date
    January 29, 2025
    Manufacturer
    TAMBRANDS MANUFACTURING, INC
    Product Code
    HEB
    UDI-DI
    00073010479050
    PMA / PMN Number
    K081555
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    PRODUCT INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 0

    COTTON IS COMING APART INSIDE OF ME- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT], COTTON IS COMING APART [DEVICE BREAKAGE] , WHEN I GO TO CHANGE MY TAMPON, THE COTTON IS COMING APART INSIDE OF ME [COMPLICATION OF DEVICE REMOVAL] . CASE NARRATIVE: CONSUMER REPORTED VIA E-MAIL THAT THE COTTON IS COMING APART INSIDE. NO SERIOUS INJURY REPORTED.

    Description of Event or Problem · 0

    COTTON IS COMING APART INSIDE OF ME- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. COTTON IS COMING APART [DEVICE BREAKAGE]. WHEN I GO TO CHANGE MY TAMPON, THE COTTON IS COMING APART INSIDE OF ME [COMPLICATION OF DEVICE REMOVAL]. CASE NARRATIVE: CONSUMER REPORTED VIA E-MAIL THAT THE COTTON IS COMING APART INSIDE. NO SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380277 TAMPAXTAMPONSPEARLFULLSIZESUPERPLUSUNSCNT18CT TAMPON, MENSTRUAL, UNSCENTED - HEB HEB TAMBRANDS MANUFACTURING, INC 4249243066680311 00073010479050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female