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U by Kotex Tampon (UDI 00036000490305)Recalls & reported problems

Kimberly-Clark Global Sales, Inc. · U BY KOTEX SUPER PREMIUM TAMPONS CLICK SUPER ABSORBENCY · Class 2

All models of U By Kotex (42)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00036000490305), received between Sep 18, 2020 and Sep 18, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Difficult to Remove2

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 18, 2020Difficult to Remove; Difficult to Remove

    COMPANION SAMPLES WERE RECEIVED FOR EVALUATION. NO PRODUCT DEFECTS OR ABNORMALITIES WERE OBSERVED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10556744 ↗
  • MalfunctionSep 18, 2020Difficult to Remove; Difficult to Remove

    COMPANION SAMPLES WERE RECEIVED FOR EVALUATION. NO PRODUCT DEFECTS OR ABNORMALITIES WERE OBSERVED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10556704 ↗

Other TAMPON, MENSTRUAL, UNSCENTED devices

All TAMPON, MENSTRUAL, UNSCENTED devices →

Sources and updates

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