U By Kotex Tampon (UDI 00036000515763)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00036000515763), received between Sep 14, 2020 and Mar 9, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11448630 ↗
• MalfunctionMar 9, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11448625 ↗
• MalfunctionMar 9, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11448590 ↗
• MalfunctionFeb 23, 2021Material Separation; Material Separation

  CONSUMER REPORTED SHE WORE A TAMPON APPROXIMATELY FOUR TO FIVE HOURS AND UPON REMOVAL THE TOP OF THE PLEDGET APPEARED TO HAVE A PIECE MISSING CAUSING HER TO BELIEVE PIECES OF PLEDGET REMAINED INSIDE HER VAGINAL CAVITY. SHE MANUALLY CHECKED FOR PLEDGET PIECES INSIDE HER VAGINAL CAVITY AND DID NOT FIND ANY PIECES. SHE CALLED HER HCP AND REPORTED HER EXPERIENCE. CONSUMER DOES NOT THINK ANY PIECES REMAINED INSIDE OF HER VAGINAL CAVITY. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS AND DID NOT SEEK MEDICAL ATTENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11368771 ↗
• MalfunctionJan 8, 2021Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11139761 ↗
• MalfunctionOct 1, 2020Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL THE STRING PULLED OUT LEAVING THE TAMPON INSIDE HER VAGINAL CAVITY. SHE WAS UNABLE TO MANUALLY REMOVE THE PLEDGET. SHE WENT TO HER GYNECOLOGIST WHO REMOVED THE 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 10613828 ↗
• MalfunctionSep 17, 2020Break; Break

  CONSUMER REPORTED UPON REMOVAL THE STRING BROKE LEAVING THE TAMPON PLEDGET INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE PLEDGET. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10548135 ↗
• MalfunctionSep 14, 2020Material Separation; Material Separation

  CONSUMER REPORTED SHE WAS UNABLE TO FIND THE STRING TO REMOVE THE TAMPON AND MANUALLY REMOVED THE PLEDGET. LATER THAT DAY SHE USED THE REST ROOM AND WHILE WIPING, SHE NOTICED THE STRING WAS HANGING OUT OF HER. SHE WAS ABLE TO REMOVE THE STRING. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS AND DID NOT SEEK MEDICAL ATTENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10527910 ↗