U by Kotex Tampon (UDI 00036000294590)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00036000294590), received between Jan 6, 2021 and Jan 6, 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.

• MalfunctionJan 6, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL THE STRING PULLED OUT OF A TAMPON AND THE PLEDGET UNRAVELED AND FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE PIECES OF PLEDGET AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11127705 ↗
• MalfunctionJan 6, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL THE STRING PULLED OUT OF A TAMPON AND THE PLEDGET UNRAVELED AND FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE PIECES OF PLEDGET AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11127702 ↗