U By Kotex Tampon (UDI 00036000515695)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00036000515695), received between Oct 14, 2020 and Jun 27, 2022 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON STRING SEPARATED FROM THE PLEDGET LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE MANUALLY REMOVED THE PLEDGET IN ONE PIECE. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14831021 ↗
• MalfunctionJun 29, 2021Material Separation; Material Separation

  CONSUMER REPORTED SHE FOUND A PIECE OF PLEDGET INSIDE HER VAGINAL CAVITY AFTER REMOVING A TAMPON SHE HAD WORN FOR TWO HOURS. SHE WAS ABLE TO MANUALLY REMOVE THE PIECE OF PLEDGET AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084510 ↗
• MalfunctionFeb 23, 2021Break; Break

  CONSUMER REPORTED UPON REMOVAL THE STRING BROKE OFF OF THE TAMPON LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE PLEDGET IN ONE PIECE. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11368897 ↗
• MalfunctionOct 14, 2020Material Separation; Material Separation

  CONSUMER REPORTED SHE WORE A TAMPON FOR SIX HOURS AND UPON REMOVAL THE PLEDGET FELL APART LEAVING A PIECE INSIDE HER VAGINAL CAVITY. SHE BELIEVED THE PIECE OF PLEDGET CAME OUT OF HER BODY ON ITS OWN. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS AND DID NOT SEEK MEDICAL ATTENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10677290 ↗