U by Kotex Tampon (UDI 00036000159493)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00036000159493), received between Jan 7, 2022 and Mar 1, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2024Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF AN UNSPECIFIED NUMBER OF REGULAR ABSORBENCY TAMPONS, THE STRING SEPARATED FROM THE PLEDGET. SHE MANUALLY REMOVED THE PLEDGET FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18816613 ↗
• MalfunctionFeb 20, 2024Material Separation; Material Separation

  CONSUMER REPORTED VIA E-MAIL THAT UPON REMOVAL OF A TAMPON, THE STRING SEPARATED FROM THE PLEDGET. THE PLEDGET WAS REMOVED FROM HER VAGINAL CAVITY IN THE EMERGENCY ROOM. SHE EXPERIENCED A HEADACHE AND NAUSEA AND WAS PRESCRIBED AN UNKNOWN ANTIBIOTIC. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S USE OF THE PRODUCT AND OUTCOME; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Foreign Body In Patient; Headache; Nausea

  MAUDE report 18739449 ↗
• MalfunctionMay 9, 2023Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED VIA EMAIL THAT A TAMPON HAD TWO APPLICATOR PETALS BENT UPWARDS, MAKING THE TAMPON UNUSABLE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 16894347 ↗
• MalfunctionDec 16, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECES FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996860 ↗
• MalfunctionDec 15, 2022Difficult to Remove; Difficult to Remove

  CONSUMER REPORTED THAT UPON REMOVAL OF A TAMPON THE STRING WAS NOT ACCESSIBLE FOR REMOVAL OF THE PLEDGET BECAUSE THE STRING WAS SWEPT UP INSIDE HER VAGINAL CAVITY AND CAUGHT ON SOMETHING UNKNOWN. IT WAS CONFIRMED SHE DID NOT HAVE AN IUD IN AT THE TIME OF USE. SHE MANUALLY PULLED THE PLEDGET OUT OF HER VAGINAL CAVITY AND THEN SHE CUT THE STRING WHICH ALLOWED HER TO LOOSEN THE STRING TO REMOVE THAT AS WELL. SHE EXPERIENCED PAIN WHEN ATTEMPTING TO REMOVE THE TAMPON. THE PAIN RESOLVED AFTER TAMPON REMOVAL. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Pain

  MAUDE report 15992198 ↗
• MalfunctionDec 15, 2022Material Separation; Material Separation

  REPORT 1 OF 2. CONSUMER REPORTED THAT UPON REMOVAL OF AN UNSPECIFIED NUMBER OF REGULAR ABSORBENCY TAMPONS THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECES FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15991149 ↗
• MalfunctionJan 7, 2022Break; Break

  CONSUMER REPORTED SHE OPENED A TAMPON FOR USE AND THE PLUNGER WAS BROKEN AND THE TAMPON STRING WAS CUT OFF. SHE DID NOT USE THE TAMPON AND DISCARDED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13192500 ↗