BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L.TAMPONSORGCOTTONCOMPAKREGNORNONDO

    MDR report key: 11343248 · Received February 18, 2021

    Report

    Report Number
    1219109-2021-00050
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Report Date
    January 20, 2021
    Manufacturer
    ONTEX HYGIENEARTIKEL GMBH
    Product Code
    HEB
    PMA / PMN Number
    K162746
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 0

    TAMPON SHREDDING INSIDE - VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT] TAMPON STRING TUGS OFF, TAMPON SHREDDING [DEVICE BREAKAGE] COTTON IS SHREDDING INSIDE WHEN I GO TO REMOVE (TAMPON) [COMPLICATION OF DEVICE REMOVAL] CONSUMER REPORTED VIA SOCIAL MEDIA THAT THE STRINGS TUG OFF, AND THE COTTON SHREDS INSIDE OF HER WHEN REMOVING THE TAMPONS. NO SERIOUS INJURY WAS REPORTED. FOLLOW-UP: PRODUCT RETURN IDENTIFIED AS ONTEX PRODUCT. PLEASE SEE REPORT 1216894-2021-00015 SINCE THE PRODUCT INVOLVED IN THIS COMPLAINT WAS NOT MANUFACTURED BY TAMBRANDS MANUFACTURING, INC. IN AUBURN, MAINE, USA.

    Additional Manufacturer Narrative · 1

    THERE IS INSUFFICIENT INFORMATION TO PERFORM A PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    TAMPON SHREDDING INSIDE - VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPON STRING TUGS OFF, TAMPON SHREDDING [DEVICE BREAKAGE]. COTTON IS SHREDDING INSIDE WHEN I GO TO REMOVE (TAMPON) [COMPLICATION OF DEVICE REMOVAL]. CASE DESCRIPTION: CONSUMER REPORTED VIA SOCIAL MEDIA THAT THE STRINGS TUG OFF, AND THE COTTON SHREDS INSIDE OF HER WHEN REMOVING THE TAMPONS. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243275 L.TAMPONSORGCOTTONCOMPAKREGNORNONDO TAMPON, MENSTRUAL, UNSCENTED HEB ONTEX HYGIENEARTIKEL GMBH 15762/5912

    Patients

    Seq Age Sex Outcome Treatment
    1