BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPAXTAMPONSPEARLFULLSIZEREGNORUNSCNT

    MDR report key: 24347210 · Received February 16, 2026

    Report

    Report Number
    1219109-2026-00034
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Report Date
    March 11, 2026
    Manufacturer
    TAMBRANDS MANUFACTURING, INC
    Product Code
    HEB
    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

    PRODUCT INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    I DISCOVERED A PIECE OF WHAT APPEARS TO BE PLASTIC FROM A WRAPPER INSIDE OF ME-VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. PIECE OF WHAT APPEARS TO BE PLASTIC FROM A (TAMPON) WRAPPER INSIDE OF ME [PRODUCT PACKAGE ASSOCIATED INJURY]. PIECE OF WHAT APPEARS TO BE PLASTIC FROM A WRAPPER (INSIDE OF ME) ¿ON THE WRAPPER, NO IMAGING APPEARED¿PHOTO SHOWS WHAT APPEARS TO BE TAMPON OVERWRAP WITH BLOOD ON IT [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA E-MAIL THAT SHE FOUND A PIECE OF THE TAMPON INSIDE OF HER. NO SERIOUS INJURY REPORTED.

    Description of Event or Problem · 0

    I DISCOVERED A PIECE OF WHAT APPEARS TO BE PLASTIC FROM A WRAPPER INSIDE OF ME-VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT] PIECE OF WHAT APPEARS TO BE PLASTIC FROM A (TAMPON) WRAPPER INSIDE OF ME [PRODUCT PACKAGE ASSOCIATED INJURY] PIECE OF WHAT APPEARS TO BE PLASTIC FROM A WRAPPER (INSIDE OF ME)¿ON THE WRAPPER, NO IMAGING APPEARED¿PHOTO SHOWS WHAT APPEARS TO BE TAMPON OVERWRAP WITH BLOOD ON IT [DEVICE BREAKAGE] . CASE NARRATIVE: CONSUMER REPORTED VIA E-MAIL THAT SHE FOUND A PIECE OF THE TAMPON INSIDE OF HER. NO SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408179 TAMPAXTAMPONSPEARLFULLSIZEREGNORUNSCNT TAMPON, MENSTRUAL, UNSCENTED - HEB HEB TAMBRANDS MANUFACTURING, INC 5343243048W05:13

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female