U By Kotex Tampon (UDI 00036000515800)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00036000515800), received between Oct 20, 2020 and Aug 24, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2021Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12360210 ↗
• MalfunctionAug 5, 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 TAMPON IN ONE PIECE. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280926 ↗
• MalfunctionJun 3, 2021Break; Break

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED SHE WORE A TAMPON A COUPLE HOURS AND UPON REMOVAL THE STRING BROKE LEAVING THE TAMPON 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 11933670 ↗
• MalfunctionJun 3, 2021Break; Material Separation; Break; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED SHE WORE A TAMPON ONE HOUR AND UPON REMOVAL THE STRING BROKE OFF LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE REPORTED THE PLEDGET CAME OUT IN LITTLE PIECES AND LATER SHE FOUND MORE PLEDGET PIECES. SHE WAS UNSURE IF SHE WAS ABLE TO REMOVE THE REMAINING PLEDGET PIECES. SHE EXPERIENCED PELVIC PAIN AND WAS UNCERTAIN IF THE PAIN WAS DUE TO HER MENSTRUAL PERIOD OR FROM THE PLEDGET FALLING APART. SHE DID NOT SEEK MEDICAL ATTENTION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S OUTCOME, HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Pain

  MAUDE report 11932177 ↗
• MalfunctionMay 12, 2021Difficult to Remove; Defective Component; Difficult to Remove; Defective Component

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED THAT UPON REMOVAL SHE COULD NOT FIND THE STRING ON THE TAMPON AND THE PLEDGET WAS LEFT INSIDE HER VAGINAL CAVITY FOR 19 HOURS. WHEN SHE REALIZED THE TAMPON WAS STILL INSIDE OF HER, SHE MANUALLY REMOVED THE PLEDGET AND NOTICED IT WAS UPSIDE DOWN. AFTER REMOVAL, SHE NOTICED THE STRING WAS ALSO SHORTER WHEN COMPARED TO THE OTHER TAMPONS FROM THE BOX. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812907 ↗
• MalfunctionMar 11, 2021Material Separation; Material Separation

  CONSUMER REPORTED SHE WORE A TAMPON APPROXIMATELY FIVE HOURS AND UPON REMOVAL THE PLEDGET FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE BELIEVED A PIECE OF PLEDGET REMAINED INSIDE HER VAGINAL CAVITY AND MADE AN APPOINTMENT TO SEE HER DOCTOR THE FOLLOWING DAY. UPON EXAMINATION HER DOCTOR DID NOT FIND ANY PIECES OF PLEDGET REMAINING. 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 11468172 ↗
• MalfunctionFeb 16, 2021Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED SHE WORE A TAMPON APPROXIMATELY SIX TO EIGHT HOURS AND UPON REMOVAL THE TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE REMAINING PIECES OF 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 11333180 ↗
• MalfunctionNov 19, 2020Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). 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 THE PIECES OF 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 10870153 ↗
• MalfunctionNov 13, 2020Difficult to Remove; Difficult to Remove

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED SHE WORE A TAMPON FOR APPROXIMATELY THREE HOURS AND UPON REMOVAL THE STRING WAS TOO SHORT TO REMOVE THE TAMPON PLEDGET FROM 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 10837818 ↗
• MalfunctionOct 20, 2020Material Separation; Material Separation

  CONSUMER REPORTED SHE WORE A TAMPON FOR APPROXIMATELY FOUR TO SIX HOURS AND UPON REMOVAL THE TAMPON PLEDGET UNRAVELED AND CAME OUT IN TWO PIECES. SHE MANUALLY REMOVED THE PLEDGET PIECES 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 10706627 ↗