BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L.TAMPONSORGCOTTONMIXEDNONDO30CT

    MDR report key: 10178131 · Received June 22, 2020

    Report

    Report Number
    9615100-2020-00018
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Report Date
    May 24, 2020
    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

    THIS REPORT WAS SUBMITTED AS A MANUFACTURER REPORT, IT SHOULD HAVE BEEN SUBMITTED AS AN INITIAL IMPORTER REPORT. THE INITIAL IMPORTER IS THE PROCTER & GAMBLE CO./THE GILLETTE CO., (B)(6) . REGISTRATION NUMBER: (B)(4). 02-JUL-2020 PRODUCT INVESTIGATION. RESULTS: NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE INVESTIGATION.

    Description of Event or Problem · 0

    UNCOMFORTABLE - VAGINA [VULVOVAGINAL DISCOMFORT]. TAMPON STRING COMING COMPLETELY UNATTACHED FROM THE COTTON ITSELF [DEVICE BREAKAGE]. CASE DESCRIPTION: CONSUMER CONTACTED VIA E-MAIL AND STATED THAT THE TAMPON STRING WAS COMING COMPLETELY UNATTACHED FROM THE COTTON ITSELF. NO SERIOUS INJURY WAS REPORTED.

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    UNCOMFORTABLE - VAGINA [VULVOVAGINAL DISCOMFORT]. TAMPON STRING COMING COMPLETELY UNATTACHED FROM THE COTTON ITSELF [DEVICE BREAKAGE]. CONSUMER CONTACTED VIA E-MAIL AND STATED THAT THE TAMPON STRING WAS COMING COMPLETELY UNATTACHED FROM THE COTTON ITSELF. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645971 L.TAMPONSORGCOTTONMIXEDNONDO30CT TAMPON, MENSTRUAL, UNSCENTED HEB ONTEX HYGIENEARTIKEL GMBH 24868/5965 13:21

    Patients

    Seq Age Sex Outcome Treatment
    1