BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB

    MDR report key: 15701902 · Received October 31, 2022

    Report

    Report Number
    3003701733-2022-00037
    Event Type
    Malfunction
    Date Received
    October 31, 2022
    Date of Event
    October 6, 2022
    Report Date
    October 31, 2022
    Manufacturer
    BERRY PLASTICS QINGDAO LTD.
    Product Code
    HEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A NON-US REPORT THAT OCCURRED IN CHINA. THE PRODUCT INVOLVED IS NOT SOLD IN THE US; HOWEVER, IT IS SIMILAR TO THE U BY KOTEX CLICK TAMPONS WITH 510K NUMBER K172118. RECORDS DEMONSTRATE THAT QUALITY SYSTEM PROCEDURES WERE CORRECTLY FOLLOWED AND THE FINISHED PRODUCT MET ALL QUALITY RELEASE CRITERIA AND SPECIFICATIONS WERE WITHIN ALLOWABLE LIMITS PRIOR TO RELEASE.

    Description of Event or Problem · 0

    THIS IS A NON-US EVENT. THIS OCCURRED IN CHINA. CONSUMER REPORTED WITH A TAMPON THE STRING COULD NOT BE USED TO PULL THE TAMPON OUT AFTER USE. MEDICAL WAS CONSULTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2952634 U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB BERRY PLASTICS QINGDAO LTD. REGULAR 20220715BPAA

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose