U by Kotex Tampon (UDI 00036000159516)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00036000159516), received between Dec 13, 2022 and Dec 16, 2022 — 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.

• MalfunctionDec 16, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECES FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996767 ↗
• MalfunctionDec 13, 2022Material Separation; Material Separation

  CONSUMER REPORTED THAT UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS, THE STRINGS SEPARATED LEAVING THE PLEDGETS INSIDE HER VAGINAL CAVITY. SHE MANUALLY REMOVED THE PLEDGETS. SHE ALSO REPORTED SHE RECEIVED LACERATIONS UPON INSERTION OF AN UNSPECIFIED NUMBER OF TAMPONS. SHE USED OVER THE COUNTER VASELINE FOR THE LACERATIONS AND IS IMPROVING. THE CONSUMER DID NOT SEEK MEDICAL ATTENTION FOR EITHER OF THE REPORTED ISSUES AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Laceration(s)

  MAUDE report 15970349 ↗