U By Kotex Tampon (UDI 00036000515794)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00036000515794), received between Sep 18, 2020 and Mar 8, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2021Difficult to Remove; Difficult to Remove

  CONSUMER REPORTED THAT PRIOR TO INSERTION THE TAMPON STRING WAS NOT HANGING OUT OF THE APPLICATOR MAKING THE STRING UNAVAILABLE TO REMOVE THE PLEDGET FROM HER VAGINAL CAVITY AFTER INSERTION. SINCE THE STRING WAS NOT AVAILABLE, SHE HAD TO MANUALLY REMOVE THE PLEDGET. AFTER REMOVAL SHE ALLEGED THE PLEDGET HAD BEEN UPSIDE DOWN INSIDE HER VAGINAL CAVITY WITH THE STRING INSERTED FIRST. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436694 ↗
• MalfunctionMar 8, 2021Difficult to Remove; Difficult to Remove

  CONSUMER REPORTED THAT PRIOR TO INSERTION THE TAMPON STRING WAS NOT HANGING OUT OF THE APPLICATOR MAKING THE STRING UNAVAILABLE TO REMOVE THE PLEDGET FROM HER VAGINAL CAVITY AFTER INSERTION. SINCE THE STRING WAS NOT AVAILABLE, SHE HAD TO MANUALLY REMOVE THE PLEDGET. AFTER REMOVAL SHE ALLEGED THE PLEDGET HAD BEEN UPSIDE DOWN INSIDE HER VAGINAL CAVITY WITH THE STRING INSERTED FIRST. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436668 ↗
• MalfunctionMar 8, 2021Difficult to Remove; Difficult to Remove

  CONSUMER REPORTED THAT PRIOR TO INSERTION THE TAMPON STRING WAS NOT HANGING OUT OF THE APPLICATOR MAKING THE STRING UNAVAILABLE TO REMOVE THE PLEDGET FROM HER VAGINAL CAVITY AFTER INSERTION. SINCE THE STRING WAS NOT AVAILABLE, SHE HAD TO MANUALLY REMOVE THE PLEDGET. AFTER REMOVAL SHE ALLEGED THE PLEDGET HAD BEEN UPSIDE DOWN INSIDE HER VAGINAL CAVITY WITH THE STRING INSERTED FIRST. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436588 ↗
• MalfunctionFeb 18, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL THE STRING PULLED OUT OF A TAMPON LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE PLEDGET IN ONE PIECE. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11343380 ↗
• MalfunctionSep 18, 2020Material Separation; Material Separation

  CONSUMER REPORTED SHE WORE A TAMPON FOR FOUR HOURS AND UPON REMOVAL THE TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE MANUALLY REMOVED A PIECE OF PLEDGET FROM HER VAGINAL CAVITY AND NOTICED MORE PLEDGET PIECES CAME OUT LATER. SHE STATED SHE HAS BEEN EXPERIENCING SOME VAGINAL CRAMPING. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Cramp(s)

  MAUDE report 10556474 ↗