BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPAX PEARL TAMPON, ABSORBENCY/SCENT UNKNOWN

    MDR report key: 22327816 · Received June 25, 2025

    Report

    Report Number
    1219109-2025-00180
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Report Date
    July 11, 2025
    Manufacturer
    TAMBRANDS MANUFACTURING, INC
    Product Code
    HEB
    PMA / PMN Number
    K081555
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS INSUFFICIENT INFORMATION TO PERFORM AN INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THERE IS INSUFFICIENT INFORMATION TO PERFORM AN INVESTIGATION.

    Description of Event or Problem · 0

    WHEN I PULL THEM OUT, THERE IS PLUSH STAYING INSIDE OF ME- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT] . THERE IS PLUSH STAYING INSIDE OF ME- TAMPAX PEARL [DEVICE BREAKAGE] WHEN I PULL THEM OUT, THERE IS PLUSH STAYING INSIDE OF ME [COMPLICATION OF DEVICE REMOVAL]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THERE IS PLUSH STAYING INSIDE OF HER AFTER TAMPON REMOVAL. NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    WHEN I PULL THEM OUT, THERE IS PLUSH STAYING INSIDE OF ME: VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. THERE IS PLUSH STAYING INSIDE OF ME: TAMPAX PEARL [DEVICE BREAKAGE]. WHEN I PULL THEM OUT, THERE IS PLUSH STAYING INSIDE OF ME [COMPLICATION OF DEVICE REMOVAL]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THERE IS PLUSH STAYING INSIDE OF HER AFTER-TAMPON REMOVAL. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143487 TAMPAX PEARL TAMPON, ABSORBENCY/SCENT UNKNOWN TAMPON, MENSTRUAL, UNSCENTED - HEB HEB TAMBRANDS MANUFACTURING, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female