U by Kotex Tampon (UDI 00036000426656)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00036000426656), received between Mar 31, 2021 and Mar 31, 2021 — classified as 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2021Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED SHE WORE A TAMPON FOR TWO HOURS AND UPON REMOVAL THE PLEDGET FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. AFTER THIS OCCURRED SHE WAS FINDING PIECES OF PLEDGET WHEN WIPING AND EXPERIENCED SEVERE LOWER ABDOMINAL PAIN AND CRAMPING. SHE WENT TO HER DOCTOR A FEW DAYS LATER WHERE THE REMAINING PIECES OF PLEDGET WERE REMOVED FROM HER VAGINAL CAVITY. CONSUMER EXPERIENCED A LINGERING HEADACHE AND ABDOMINAL CRAMPING. SHE WAS PRESCRIBED NAPROXEN FOR THE PAIN. SHE WAS INSTRUCTED TO CALL HER DOCTOR FOR AN ANTIBIOTIC IF HER HEADACHE AND CRAMPING CONTINUED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S OUTCOME AND ANY ADDITIONAL MEDICAL TREATMENT, HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Abdominal Cramps; Abdominal Pain; Headache

  MAUDE report 11598933 ↗