BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L.TAMPONSORGCOTTONCOMPAKSUPERNONDO

    MDR report key: 12592671 · Received October 7, 2021

    Report

    Report Number
    1216894-2021-00102
    Event Type
    Injury
    Date Received
    October 7, 2021
    Report Date
    September 7, 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 · 1

    TAMPONS FALL APART INSIDE YOU-VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPONS FALL APART INSIDE YOU [DEVICE BREAKAGE]. CASE DESCRIPTION: CONSUMER REPORTED VIA EMAIL THAT THE TAMPONS FALL APART INSIDE OF HER. NO SERIOUS INJURY WAS REPORTED LOT CODES: 34662/6078 11:40, 00362/6094 00:35, 33162/6042 02:41.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1491566 L.TAMPONSORGCOTTONCOMPAKSUPERNONDO TAMPON, MENSTRUAL, UNSCENTED HEB ONTEX HYGIENEARTIKEL GMBH SEE B5 FOR COMPLETE LISTING

    Patients

    Seq Age Sex Outcome Treatment
    1