BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L.TAMPONSORGCOTTONCOMPAKREGNORNONDO

    MDR report key: 12482426 · Received September 16, 2021

    Report

    Report Number
    1219109-2021-00346
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Report Date
    August 20, 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

    COTTON FROM TAMPON STAYS INSIDE [FOREIGN BODY IN REPRODUCTIVE TRACT] COTTON COMES OFF THE TAMPON [DEVICE BREAKAGE] CAUSE WAS TRACED TO DESIGN [PRODUCT DESIGN ISSUE] CASE DESCRIPTION: CONSUMER REPORTED VIA E-MAIL THAT COTTON COMES OFF TAMPON. NO SERIOUS INJURY REPORTED. LOT CODES: 33264/6047, 35564/6056, 34664/6056, 35164/6056, 35064/6056, 33364/6047 FOLLOW-UP: 11-OCT-2021: RETURNED PRODUCT IDENTIFIED AS ONTEX L. PLEASE SEE REPORTS 1216894-2021-00113 & 1216894-2021-00114 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

    COTTON FROM TAMPON STAYS INSIDE [FOREIGN BODY IN REPRODUCTIVE TRACT]. COTTON COMES OFF THE TAMPON [DEVICE BREAKAGE]. CASE DESCRIPTION: CONSUMER REPORTED VIA E-MAIL THAT COTTON COMES OFF TAMPON. NO SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381669 L.TAMPONSORGCOTTONCOMPAKREGNORNONDO TAMPON, MENSTRUAL, UNSCENTED HEB ONTEX HYGIENEARTIKEL GMBH SEE B5 FOR COMPLETE LISTING

    Patients

    Seq Age Sex Outcome Treatment
    1 Female