BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPAXTAMPONSPEARLFULLSIZEREGNORUNSCNT

    MDR report key: 23475598 · Received November 5, 2025

    Report

    Report Number
    1219109-2025-00320
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Report Date
    December 12, 2025
    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.

    Additional Manufacturer Narrative · 0

    THERE IS INSUFFICIENT INFORMATION TO PERFORM AN INVESTIGATION

    Description of Event or Problem · 0

    HURTS, VAGINA [VULVOVAGINAL PAIN]. PULLING TAMPON STRING AND SCRAPING MY PRIVATES, VAGINA [VULVOVAGINAL INJURY]. TAMPONS ARE IN THE TUBE UPSIDE DOWN, TAMPAX PEARL [DEVICE PHYSICAL PROPERTY ISSUE]. WHEN I GO TO PULL IT OUT, IT HURTS. PULLING THE TAMPON STRING AND SCRAPING PRIVATES [COMPLICATION OF DEVICE REMOVAL]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPONS ARE IN THE TUBE UPSIDE DOWN. NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    HURTS, VAGINA [VULVOVAGINAL PAIN]. PULLING TAMPON STRING AND SCRAPING MY PRIVATES- VAGINA [VULVOVAGINAL INJURY] TAMPONS ARE IN THE TUBE UPSIDE DOWN- TAMPAX PEARL [DEVICE PHYSICAL PROPERTY ISSUE] WHEN I GO TO PULL IT OUT, IT HURTS. PULLING THE TAMPON STRING AND SCRAPING PRIVATES [COMPLICATION OF DEVICE REMOVAL]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPONS ARE IN THE TUBE UPSIDE DOWN. NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    HURTS - VAGINA [VULVOVAGINAL PAIN] . PULLING TAMPON STRING AND SCRAPING MY PRIVATES- VAGINA [VULVOVAGINAL INJURY] . TAMPONS ARE IN THE TUBE UPSIDE DOWN- TAMPAX PEARL [DEVICE PHYSICAL PROPERTY ISSUE] . WHEN I GO TO PULL IT OUT, IT HURTS... PULLING THE TAMPON STRING AND SCRAPING PRIVATES .[COMPLICATION OF DEVICE REMOVAL] . CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPONS ARE IN THE TUBE UPSIDE DOWN. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2404047 TAMPAXTAMPONSPEARLFULLSIZEREGNORUNSCNT TAMPON, MENSTRUAL, UNSCENTED - HEB HEB TAMBRANDS MANUFACTURING, INC 5193243045W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female