BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L.TAMPONSORGCOTTONCOMPAKREGNORNONDO

    MDR report key: 12319514 · Received August 13, 2021

    Report

    Report Number
    1219109-2021-00298
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Report Date
    July 14, 2021
    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

    CAUSE WAS TRACED TO DESIGN. ACTION ITEM IS IN PLACE.

    Description of Event or Problem · 0

    TAMPONS FALL APART INSIDE YOU-VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPONS FALL APART INSIDE YOU [DEVICE BREAKAGE]. CAUSE WAS TRACED TO DESIGN [MANUFACTURING ISSUE]. CASE DESCRIPTION: CONSUMER REPORTED VIA EMAIL THAT THE TAMPONS FALL APART INSIDE OF HER. NO SERIOUS INJURY WAS REPORTED. FOLLOW-UP: 07-SEP-2021: RETURNED PRODUCT IDENTIFIED AS ONTEX L. PLEASE SEE REPORTS 1216894-2021-00101 & 1216894-2021-00102 FOR THE 2 REPORTS REGARDING THE REGULAR AND SUPER PRODUCTS RESPECTIVELY THAT WERE NOT MANUFACTURED BY TAMBRANDS MANUFACTURING, INC. IN AUBURN, MAINE, USA.

    Additional Manufacturer Narrative · 1

    THERE IS INSUFFICIENT INFORMATION TO PERFORM A PRODUCT INVESTIGATION.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217613 L.TAMPONSORGCOTTONCOMPAKREGNORNONDO TAMPON, MENSTRUAL, UNSCENTED HEB ONTEX HYGIENEARTIKEL GMBH 30964/6047 06:47

    Patients

    Seq Age Sex Outcome Treatment
    1