BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L.TAMPONSORGCOTTONCOMPAKREGNORNONDO45CT

    MDR report key: 12280330 · Received August 5, 2021

    Report

    Report Number
    1216894-2021-00081
    Event Type
    Injury
    Date Received
    August 5, 2021
    Report Date
    July 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

    PLASTIC PIECES IS BROKEN. I HAVE NO IDEA IF IT'S NOW INSIDE ME -VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. ONE OF THE PLASTIC PIECES IS BROKEN [DEVICE PHYSICAL PROPERTY ISSUE]. CONSUMER REPORTED VIA EMAIL THAT AFTER INSERTING A TAMPON SHE NOTICED THAT THE PLASTIC APPLICATOR WAS BROKEN. NO SERIOUS INJURY WAS REPORTED. LOT CODES: 1088831 20:12, 00348/6089 23:32, 33364/6047 15:47, 34564/6056 23:15, 16864/5887 17:41.

    Description of Event or Problem · 0

    PLASTIC PIECES IS BROKEN. I HAVE NO IDEA IF IT'S NOW INSIDE ME -VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. ONE OF THE PLASTIC PIECES IS BROKEN [DEVICE PHYSICAL PROPERTY ISSUE]. CASE DESCRIPTION: CONSUMER REPORTED VIA EMAIL THAT AFTER INSERTING A TAMPON SHE NOTICED THAT THE PLASTIC APPLICATOR WAS BROKEN. NO SERIOUS INJURY WAS REPORTED. FOLLOW-UP 23-SEP-2021: THERE IS INSUFFICIENT INFORMATION TO PERFORM A PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    PLASTIC PIECES IS BROKEN. I HAVE NO IDEA IF IT'S NOW INSIDE ME -VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. ONE OF THE PLASTIC PIECES IS BROKEN [DEVICE PHYSICAL PROPERTY ISSUE]. CASE DESCRIPTION: CONSUMER REPORTED VIA EMAIL THAT AFTER INSERTING A TAMPON SHE NOTICED THAT THE PLASTIC APPLICATOR WAS BROKEN. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180848 L.TAMPONSORGCOTTONCOMPAKREGNORNONDO45CT TAMPON, MENSTRUAL, UNSCENTED HEB ONTEX HYGIENEARTIKEL GMBH SEE B5 FOR COMPLETE LISTING

    Patients

    Seq Age Sex Outcome Treatment
    1