BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L.TAMPONSORGCOTTONCOMPAKREGNORNONDO

    MDR report key: 12751005 · Received November 4, 2021

    Report

    Report Number
    1219109-2021-00401
    Event Type
    Malfunction
    Date Received
    November 4, 2021
    Report Date
    October 5, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    LEFT COTTON RESIDUE IN ME- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPON COTTON CAME APART [DEVICE BREAKAGE]. WHEN REMOVING A TAMPON THE COTTON CAME APART INSIDE ME [COMPLICATION OF DEVICE REMOVAL]. CAUSE WAS TRACED TO DESIGN [PRODUCT DESIGN ISSUE]. CASE DESCRIPTION: CONSUMER REPORTED VIA E-MAIL THAT COTTON CAME APART DURING TAMPON REMOVAL. NO SERIOUS INJURY REPORTED. FOLLOW-UP: 06-DEC-2021: RETURNED PRODUCT IDENTIFIED AS ONTEX L.PLEASE SEE REPORTS 1216894-2022-00001 AND 1216894-2022-00002 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

    LEFT COTTON RESIDUE IN ME- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPON COTTON CAME APART [DEVICE BREAKAGE]. WHEN REMOVING A TAMPON THE COTTON CAME APART INSIDE ME [COMPLICATION OF DEVICE REMOVAL]. CASE DESCRIPTION: CONSUMER REPORTED VIA E-MAIL THAT COTTON CAME APART DURING TAMPON REMOVAL. NO SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1652360 L.TAMPONSORGCOTTONCOMPAKREGNORNONDO TAMPON, MENSTRUAL, UNSCENTED HEB ONTEX HYGIENEARTIKEL GMBH 18062/5939 09:11

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female