U by Kotex Tampon (UDI 00036000490299)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00036000490299), received between Sep 16, 2020 and Feb 3, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2021Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE PLEDGET PIECES AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11272926 ↗
• MalfunctionSep 18, 2020Material Separation; Material Separation

  CONSUMER REPORTED THE STRING CAME OFF OF A TAMPON UPON REMOVAL LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE EXPERIENCED CRAMPING WHICH RESOLVED AFTER REMOVING THE TAMPON PLEDGET FROM HER VAGINAL CAVITY. CONSUMER ALSO REPORTED THAT AFTER REMOVAL SHE NOTICED THE TAMPON WAS CRUMBLING ON THE INSIDE. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Cramp(s)

  MAUDE report 10556484 ↗
• MalfunctionSep 16, 2020Material Separation; Material Separation

  CONSUMER REPORTED HER DAUGHTER HAD THE STRING PULL OUT OF A TAMPON UPON REMOVAL LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. HER DAUGHTER WAS UNABLE TO REMOVE THE PLEDGET AND WAS BROUGHT TO THE ER. ER PROVIDER REMOVED THE PLEDGET WHICH WAS PAINFUL FOR HER DAUGHTER. SHE STATED THE PAIN CONTINUED FOR TWO DAYS. HER DAUGHTER TOOK IBUPROFEN AND HER PAIN RESOLVED. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Pain

  MAUDE report 10541310 ↗