U By Kotex Tampon (UDI 00036000515749)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00036000515749), received between Sep 23, 2020 and Aug 24, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 16, 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.

• MalfunctionAug 24, 2021Break; Material Separation; Break; Material Separation

  CONSUMER REPORTED SHE REMOVED A TAMPON AND NOTICED PLEDGET AND STRING PIECES LEFT BEHIND INSIDE HER VAGINAL CAVITY. SHE CALLED THE DOCTOR AND THEY ADVISED HER TO GO TO THE ER. SHE WENT TO THE ER WHERE THE PLEDGET PIECES WERE SUCCESSFULLY REMOVED FROM HER VAGINAL CAVITY. SHE DID NOT RECEIVE ANY ADDITIONAL MEDICAL TREATMENT AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12359916 ↗
• MalfunctionMar 9, 2021Difficult to Remove; Component Missing; Difficult to Remove; Component Missing

  CONSUMER REPORTED SHE COULD NOT FIND THE STRING ON A TAMPON TO REMOVE THE PLEDGET FROM HER VAGINAL CAVITY. WHILE THE PLEDGET REMAINED INSIDE HER VAGINAL CAVITY SHE INSERTED ANOTHER TAMPON. SHE WAS ABLE TO REMOVE THE SECOND TAMPON BUT THE FIRST TAMPON REMAINED INSIDE HER VAGINAL CAVITY. SHE WAS UNABLE TO REMOVE THE PLEDGET ON HER OWN. AFTER APPROXIMATELY TWO WEEKS SHE WENT TO HER DOCTOR. HER DOCTOR PERFORMED A VAGINAL EXAM AND NO TAMPON WAS FOUND. HER DOCTOR TOLD HER SHE MUST HAVE REMOVED THE TAMPON WITH THE SECOND TAMPON SHE INSERTED. SHE WAS FEELING FINE AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11448607 ↗
• MalfunctionFeb 19, 2021Material Separation; Material Separation

  CONSUMER REPORTED SHE WORE A TAMPON APPROXIMATELY ONE AND A HALF HOURS AND UPON REMOVAL THE STRING PULLED OUT IN ONE LONG STRAND LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. DURING MANUAL REMOVAL THE PLEDGET FELL APART INTO PIECES. SHE EXPERIENCED SEVERE CRAMPS THAT WERE MUCH STRONGER THAN USUAL. SHE REPORTED SHE WAS GOING TO THE DOCTOR TO ENSURE NO PLEDGET PIECES REMAINED INSIDE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S OUTCOME AND MEDICAL TREATMENT, IF ANY, HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Abdominal Cramps

  MAUDE report 11355497 ↗
• MalfunctionFeb 2, 2021Difficult to Insert; Difficult to Insert

  CONSUMER REPORTED THAT AFTER INSERTING A TAMPON SHE PULLED OUT THE APPLICATOR BUT ONLY THE PLUNGER CAME OUT. THE APPLICATOR BARREL REMAINED INSIDE OF HER VAGINAL CAVITY ALONG WITH THE TAMPON. SHE WAS ABLE TO MANUALLY REMOVE THE BARREL WITH 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 11269418 ↗
• MalfunctionOct 9, 2020Component Missing; Component Missing

  CONSUMER REPORTED THE STRING WAS MISSING FROM A TAMPON. SHE WAS ABLE TO MANUALLY REMOVE THE PLEDGET FROM HER VAGINAL CAVITY, AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10659119 ↗
• MalfunctionSep 23, 2020Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL THE STRING PULLED OUT OF THE TAMPON AND SHE WAS UNABLE TO REMOVE THE PLEDGET FROM HER VAGINAL CAVITY. SHE WENT TO THE ER WHERE THE ER PROVIDER REMOVED THE PLEDGET FROM HER VAGINAL CAVITY. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS AND DID NOT RECEIVE ANY ADDITIONAL MEDICAL TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10575589 ↗
• MalfunctionSep 23, 2020Break; Break

  CONSUMER REPORTED UPON REMOVAL THE TAMPON STRING BROKE AND SHE WAS UNABLE TO REMOVE THE PLEDGET FROM HER VAGINAL CAVITY. SHE WENT TO THE ER WHERE THE ER PROVIDER REMOVED THE PLEDGET FROM HER VAGINAL CAVITY. SHE STATED THE ER PROVIDER OFFERED HER AMOXICILLIN TO PREVENT INFECTION WHICH SHE DECLINED. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS AND DID NOT RECEIVE ANY ADDITIONAL MEDICAL TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10575583 ↗