U by Kotex Tampon (UDI 00036000426649)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00036000426649), received between Dec 14, 2018 and Nov 25, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Dec 11, 2018Class IITerminated

   Potential for tampon to come apart upon removal.

   Z-0749-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionNov 25, 2020Material Separation; Material Separation

  CONSUMER REPORTED SHE WORE A TAMPON FOR EIGHT HOURS AND UPON REMOVAL THE TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WENT TO HER DOCTOR AND HER DOCTOR PERFORMED A VAGINAL EXAM. DURING THE VAGINAL EXAM, THE DOCTOR REMOVE MORE PIECES OF PLEDGET FROM HER VAGINAL CAVITY. SHE DID NOT RECEIVE ANY ADDITIONAL MEDICAL TREATMENT AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10900126 ↗
• MalfunctionDec 14, 2018Material Fragmentation

  TAMPON COMPLETELY FELL APART AND SHREDDED UPON REMOVAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8169623 ↗