BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17215665 · Received June 28, 2023

    Report

    Report Number
    3003701733-2023-00002
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    May 31, 2023
    Report Date
    June 28, 2023
    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. A MANUFACTURER LOT CODE WAS NOT PROVIDED. WITH NO MEANS TO ASCERTAIN THE MANUFACTURER/ASSET LINE AND DAY OF PRODUCTION, NO FURTHER INVESTIGATION ON THIS SPECIFIC LOT CAN BE PERFORMED. H3 : NOT RETURNED TO MANUFACTURE.

    Description of Event or Problem · 0

    THIS IS A NON-US EVENT. THIS OCCURRED IN CHINA. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING BROKE. MEDICAL TREATMENT WAS RECEIVED TO REMOVE THE PLEDGET FROM HER VAGINAL CAVITY. SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS AND NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1571138 U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB BERRY PLASTICS QINGDAO LTD. SUPER

    Patients

    Seq Age Sex Outcome Treatment
    1 Female