U by Kotex Tampon (UDI 00036000426663)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00036000426663), received between Feb 19, 2019 and Sep 17, 2020 — classified as 1 injury, 1 malfunction.

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

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.

• MalfunctionSep 17, 2020Material 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 PLEDGET PIECES AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10550018 ↗
• InjuryFeb 19, 2019Unraveled Material

  ON THE MORNING OF (B)(6) 2018, I TRIED TO REMOVE THE TAMPON THAT I HAD USED THE LATE EVENING OF (B)(6) 2018. THE TAMPON UNRAVELED, CAME APART INSIDE OF MY VAGINA AND SEPARATED INTO SEVERAL PIECES WHILE STILL INSIDE OF ME. WHEN I TRIED TO GET ALL THE PIECES OUT, IT SEVERELY SCRATCHED THE INSIDE OF MY VAGINA IN SEVERAL PLACES AND I BEGAN TO BLEED MORE HEAVILY THAN EVER BEFORE IN MY LIFE. WITHIN MINUTES I, ALSO BEGAN TO HAVE INCREASING PAIN IN MY PELVIC AREA. I TRIED FOR SEVERAL MINUTES TO REMOVE ALL THE REMAINING PIECES, BUT THE BLOOD WAS HEAVY AND I HAD TO STOP BECAUSE OF THE PAIN AND THE BLEEDING. I CALLED MY HUSBAND IN THE U.S. AND ASKED HIM TO CALL MY DOCTOR. HE COULD NOT GET IN TOUCH WITH HER, BUT DID TELL ME THAT THE TYPE OF TAMPON I HAD USED WAS RE-CALLED BY THE MAKER AND NOT TO USE ANY MORE THAT I HAD WITH ME. I CONTINUED TO HAVE PROBLEMS FOR THE NEXT THREE WEEKS AND WENT TO SEEK MEDICAL HELP TWICE IN (B)(6). UNFORTUNATELY, WHEN I DESCRIBED WHAT HAPPENED, THE GENERAL DOCTORS THERE TOLD ME THEY NEVER HEARD OF ANYTHING SUCH AS A TAMPON BREAKING INSIDE OF SOMEONE, AND TO GO HOME BECAUSE I WAS JUST HAVING MY PERIOD. I WAS PRESCRIBED MEDICINE FOR THE PAIN I WAS EXPERIENCING. I REM

  Patient problems: Abrasion; Device Embedded In Tissue or Plaque; Heavier Menses; Pain

  MAUDE report 8359284 ↗