U by Kotex Tampon (UDI 00036000157345)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00036000157345), received between Oct 1, 2020 and Mar 16, 2021 — classified as 2 malfunctions.

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

Recent adverse event reports

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

• MalfunctionMar 16, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL THE STRING PULLED OUT OF A TAMPON LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE WAS UNABLE TO REMOVE THE PLEDGET ON HER OWN. SHE WENT TO URGENT CARE WHERE A DOCTOR REMOVED THE PLEDGET. SHE DID NOT RECEIVE ANY ADDITIONAL MEDICAL TREATMENT AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11496984 ↗
• MalfunctionOct 1, 2020Material Separation; Material Separation

  CONSUMER REPORTED THE STRINGS PULLED OUT OF AN UNSPECIFIED AMOUNT OF TAMPONS PRIOR TO USE. SHE DID NOT USE THE AFFECTED TAMPONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10616539 ↗