BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN

    MDR report key: 11405572 · Received March 3, 2021

    Report

    Report Number
    1219109-2021-00068
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Report Date
    February 3, 2021
    Manufacturer
    TAMBRANDS MANUFACTURING, INC
    Product Code
    HEB
    PMA / PMN Number
    K110669
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: PRODUCT UPDATED TO TAMPAX TAMPONS RADIANT (D1) AND 510(K) UPDATED TO K110669 (G5). THERE IS INSUFFICIENT INFORMATION TO PERFORM A PRODUCT INVESTIGATION.

    Description of Event or Problem · 0

    TINY FIBERS IN VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. INSERTED TAMPON, FELT WRONG [COMPLICATION OF DEVICE INSERTION]. TAMPON LEFT TINY FIBERS IN VAGINA [DEVICE BREAKAGE]. CERVIX IRRITATED, FEELS AWFUL [CERVIX DISORDER]: CONSUMER REPORTED VIA SOCIAL MEDIA THAT WHEN SHE INSERTED THE TAMPON, IT FELT WRONG, AND TINY FIBERS WERE LEFT BEHIND IN HER VAGINA. NO SERIOUS INJURY WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THERE IS INSUFFICIENT INFORMATION TO PERFORM A PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    TINY FIBERS IN VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. INSERTED TAMPON, FELT WRONG [COMPLICATION OF DEVICE INSERTION]. TAMPON LEFT TINY FIBERS IN VAGINA [DEVICE BREAKAGE]. CERVIX IRRITATED, FEELS AWFUL [CERVIX DISORDER]. CASE DESCRIPTION: CONSUMER REPORTED VIA SOCIAL MEDIA THAT WHEN SHE INSERTED THE TAMPON, IT FELT WRONG, AND TINY FIBERS WERE LEFT BEHIND IN HER VAGINA. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304349 TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN TAMPON, MENSTRUAL, UNSCENTED HEB TAMBRANDS MANUFACTURING, INC NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1