U By Kotex Tampon (UDI 00036000515725)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00036000515725), received between Mar 23, 2021 and Mar 23, 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 23, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE REMAINING PIECES 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 11553200 ↗
• MalfunctionMar 23, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL THE STRING PULLED OUT OF THE TAMPON LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE 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 11553199 ↗