BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPAXTAMPONSPEARLFULLSIZESUPERUNSCNT18CT

    MDR report key: 23293763 · Received October 15, 2025

    Report

    Report Number
    1219109-2025-00304
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Report Date
    November 5, 2025
    Manufacturer
    TAMBRANDS MANUFACTURING, INC
    Product Code
    HEB
    PMA / PMN Number
    K081555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    TAMPON STRINGS SHEDDING, FIBERS THAT I KEEP FINDING [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPON STRINGS HAVE BEEN THREADING OFF, LEAVING SMALL BITS EVERYWHERE. CONFIRMED THAT AFFECTED TAMPONS WERE NOT USED AND NO INJURY WAS REPORTED. LOT CODES: 5 227 2080 V2 19:08 2, 5 210 2080 V1 15:49 2.

    Description of Event or Problem · 0

    TAMPON STRINGS SHEDDING, FIBERS THAT I KEEP FINDING [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPON STRINGS HAVE BEEN THREADING OFF, LEAVING SMALL BITS EVERYWHERE. CONFIRMED THAT AFFECTED TAMPONS WERE NOT USED AND NO INJURY WAS REPORTED. LOT CODES: 5 227 2080 V2 19:08 2, 5 210 2080 V1 15:49 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288976 TAMPAXTAMPONSPEARLFULLSIZESUPERUNSCNT18CT TAMPON, MENSTRUAL, UNSCENTED - HEB HEB TAMBRANDS MANUFACTURING, INC SEE B5 FOR COMPLETE LISTING

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female