BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L.TAMPONSORGCOTTONCOMPAKREGNORNONDO

    MDR report key: 11940223 · Received June 4, 2021

    Report

    Report Number
    1216894-2021-00047
    Event Type
    Injury
    Date Received
    June 4, 2021
    Report Date
    May 6, 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

    COTTON WAS STUCK IN MY VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. COTTON WAS SEVERELY DISMANTLED [DEVICE BREAKAGE]. TOOK MY L. TAMPON OUT AND THE COTTON WAS SEVERELY DISMANTLED [COMPLICATION OF DEVICE REMOVAL]. PERIOD ISSUES [MENSTRUAL DISORDER]. WEIRD VAGINAL BLEEDING, CLOTTING [VAGINAL HAEMORRHAGE]. CASE DESCRIPTION: CONSUMER REPORTED VIA EMAIL THAT THE TAMPON DISMANTLED WHILE INSIDE THE VAGINA AND A GREAT DEAL OF THE COTTON WAS STUCK IN MY VAGINA. NO SERIOUS INJURY WAS REPORTED. [(B)(6) 2021]: NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE INVESTIGATION BY THE MANUFACTURER.

    Description of Event or Problem · 1

    COTTON WAS STUCK IN MY VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. COTTON WAS SEVERELY DISMANTLED [DEVICE BREAKAGE]. TOOK MY L. TAMPON OUT AND THE COTTON WAS SEVERELY DISMANTLED [COMPLICATION OF DEVICE REMOVAL]. PERIOD ISSUES [MENSTRUAL DISORDER]. WEIRD VAGINAL BLEEDING, CLOTTING [VAGINAL HAEMORRHAGE]. CONSUMER REPORTED VIA EMAIL THAT THE TAMPON DISMANTLED WHILE INSIDE THE VAGINA AND A GREAT DEAL OF THE COTTON WAS STUCK IN MY VAGINA. NO SERIOUS INJURY WAS REPORTED. A PRODUCT INVESTIGATION IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837031 L.TAMPONSORGCOTTONCOMPAKREGNORNONDO TAMPON, MENSTRUAL, UNSCENTED HEB ONTEX HYGIENEARTIKEL GMBH 23264/5953 21:00

    Patients

    Seq Age Sex Outcome Treatment
    1