BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L.TAMPONSORGCOTTONCOMPAKMIXEDNONDO

    MDR report key: 10315878 · Received July 23, 2020

    Report

    Report Number
    9615100-2020-00024
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Report Date
    June 27, 2020
    Manufacturer
    ONTEX HYGIENEARTIKEL GMBH
    Product Code
    HEB
    PMA / PMN Number
    K162746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ONTEX COMPACT TAMPON WAS NOT INVOLVED IN THIS CASE. PLEASE SEE #1219109-2020-00316 FOR THE AUBURN FULL-SIZE TAMPON PRODUCT REPORT.

    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., 2 PROCTER AND GAMBLE PLZ, CINCINNATI, OH 45202. REGISTRATION NUMBER: 1216894. 30-JUL-2020 PRODUCT INVESTIGATION RESULTS: CAUSE WAS TRACED TO MANUFACTURING. ACTION PLAN IS IN PLACE.

    Description of Event or Problem · 0

    CONSUMER SENT E-MAIL STATING THE STRAND BROKE OFF WHEN SHE WENT TO PULL OUT THE TAMPON. NO INJURY WAS REPORTED.

    Description of Event or Problem · 0

    CONSUMER SENT E-MAIL STATING THE STRAND BROKE OFF WHEN SHE WENT TO PULL OUT THE TAMPON. NO INJURY WAS REPORTED.

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    CONSUMER SENT E-MAIL STATING THE STRAND BROKE OFF WHEN SHE WENT TO PULL OUT THE TAMPON. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780153 L.TAMPONSORGCOTTONCOMPAKMIXEDNONDO TAMPON, MENSTRUAL, UNSCENTED HEB ONTEX HYGIENEARTIKEL GMBH 004590561M

    Patients

    Seq Age Sex Outcome Treatment
    1