BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L.TAMPONSORGCOTTONCOMPAKREGNORNONDO

    MDR report key: 11530719 · Received March 19, 2021

    Report

    Report Number
    1216894-2021-00015
    Event Type
    Injury
    Date Received
    March 19, 2021
    Report Date
    January 20, 2021
    Manufacturer
    ONTEX HYGIENEARTIKEL GMBH
    Product Code
    HEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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. 25-MAR-2021: NO MANUFACTURING CAUSE IDENTIFIED BASED ON 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 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424723 L.TAMPONSORGCOTTONCOMPAKREGNORNONDO TAMPON, MENSTRUAL, UNSCENTED HEB ONTEX HYGIENEARTIKEL GMBH 15762/5912

    Patients

    Seq Age Sex Outcome Treatment
    1