U by Kotex Tampon (UDI 00036000423389)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00036000423389), received between Dec 11, 2020 and Dec 11, 2020 — 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 11, 2020Material Separation; Material Separation

  CONSUMER REPORTED THE STRING PULLED OUT OF AN UNSPECIFIED AMOUNT OF TAMPONS LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE HAD TO MANUALLY REMOVE THE PLEDGET. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10993052 ↗
• MalfunctionDec 11, 2020Material Separation; Material Separation

  CONSUMER REPORTED THE STRING PULLED OUT OF AN UNSPECIFIED AMOUNT OF TAMPONS LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE HAD TO MANUALLY REMOVE THE PLEDGET. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10993050 ↗