BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX : TAMPON, MENSTRUAL, UNSCENTED : HEB

    MDR report key: 13172940 · Received January 5, 2022

    Report

    Report Number
    3003701733-2022-00002
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    August 17, 2021
    Report Date
    January 5, 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 (B)(6). THE PRODUCT INVOLVED IS NOT SOLD IN THE US; HOWEVER, IT IS SIMILAR TO THE U BY KOTEX CLICK TAMPONS WITH 510K NUMBER K172118. A VISUAL INSPECTION OF THE RETURNED SAMPLE WAS CONDUCTED AND OBSERVED THE STRING WAS MISSING FROM THE PLEDGET. THE CAUSE WAS LIKELY DUE TO THE MANUFACTURING/ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED THE STRING WAS MISSING FROM A TAMPON. SHE NOTICED PRIOR TO USE AND DID NOT USE THIS TAMPON. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31703 U BY KOTEX : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB BERRY PLASTICS QINGDAO LTD. SUPER 20210318BPAA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female