U By Kotex KOTEX TAMPONS (UDI 00036000515893)Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00036000515893), received between Feb 24, 2021 and Sep 1, 2026 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Material Separation” (39 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Material Separation

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50543114 ↗
• MalfunctionSep 1, 2026Material Separation

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50543024 ↗
• MalfunctionAug 13, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50233827 ↗
• MalfunctionAug 6, 2026Material Separation

  Patient problems: Foreign Body In Patient

  MAUDE report 50155893 ↗
• MalfunctionMay 8, 2026Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A SUPER ABSORBENCY TAMPON, THE PLEDGET UNRAVELED AND LEFT A PIECE INSIDE OF HER VAGINAL CAVITY. SHE MANUALLY REMOVED THE PIECE AND DID NOT REQUIRE ANY MEDICAL ASSISTANCE. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125402 ↗
• MalfunctionApr 23, 2026Product Quality Problem

  CONSUMER REPORTED THAT TWO DAYS AFTER FINISHING HER MENSTRUAL CYCLE AND AFTER HAVING INTERCOURSE, SHE REMOVED A PIECE OF PLASTIC FROM HER VAGINAL CAVITY. IN THE DAYS FOLLOWING THE END OF HER CYCLE, SHE REPORTED FEELING NAUSEOUS, HOT/COLD, AND CRAMPS. SHE REPORTED TAKING ADVIL. SHE SOUGHT MEDICAL ATTENTION IN WHICH TESTS AND A VAGINAL EXAM CONFIRMED THERE WERE NO FOREIGN MATERIALS IN HER BODY AND NO INFECTION. SHE HAS SINCE IMPROVED.

  Patient problems: Cramp(s) /Muscle Spasm(s); Nausea

  MAUDE report 24971101 ↗
• MalfunctionJul 16, 2025Material Separation; Material Separation

  CONSUMER REPORTED, UPON REMOVAL OF A SUPER ABSORBENCY TAMPON, THE STRING SEPARATED IN ONE PIECE FROM THE PLEDGET. SHE WENT TO THE EMERGENCY ROOM FOR ASSISTANCE TO REMOVE THE PLEDGET FROM HER VAGINAL CAVITY AND SAYS SHE IS OK. SHE DID NOT REPORT ANY SERIOUS ADVERSE EVENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 22518606 ↗
• MalfunctionFeb 24, 2025Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON THAT THE STRING SEPARATED FROM THE PLEDGET, LEAVING IT INSIDE HER VAGINAL CAVITY. SHE REPORTED THAT IF SHE WAS NOT ABLE TO MANUALLY REMOVE THE PLEDGET THEN SHE WOULD SEEK MEDICAL ASSISTANCE. SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS. THE CONSUMER DISCONNECTED THE PHONE CALL EARLY. AN ATTEMPT WAS MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S USE OF THE PRODUCT AND OUTCOME; HOWEVER, THE CONTACT INFORMATION PROVIDED BY THE CONSUMER WAS NOT VALID AND THE CONSUMER DID NOT CALL BACK. THEREFORE, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446033 ↗
• MalfunctionMar 4, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE CALLED HER OBGYN'S NURSE AND WAS ADVISED TO MANUALLY CHECK HER VAGINAL CAVITY FOR ANY EXTRA PIECES. SHE DID NOT SEEK FURTHER MEDICAL ATTENTION AND WAS CONFIDENT ALL OF THE PIECES WERE REMOVED. SHE EXPERIENCED SOME PELVIC CRAMPING, WHICH RESOLVED, AND SHE WAS UNSURE IF THE CRAMPING WAS DUE TO HER PERIOD OR THIS INCIDENT. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 13666813 ↗
• MalfunctionMar 4, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE CALLED HER OBGYN'S NURSE AND WAS ADVISED TO MANUALLY CHECK HER VAGINAL CAVITY FOR ANY EXTRA PIECES. SHE DID NOT SEEK FURTHER MEDICAL ATTENTION AND WAS CONFIDENT ALL OF THE PIECES WERE REMOVED. SHE EXPERIENCED SOME PELVIC CRAMPING, WHICH RESOLVED, AND SHE WAS UNSURE IF THE CRAMPING WAS DUE TO HER PERIOD OR THIS INCIDENT. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 13666800 ↗
• MalfunctionFeb 7, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL MULTIPLE TAMPONS FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE REMAINING PLEDGET 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 13472065 ↗
• MalfunctionFeb 7, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL MULTIPLE TAMPONS FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE REMAINING PLEDGET 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 13472032 ↗
• MalfunctionJan 4, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL MULTIPLE TAMPONS FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE HAD TO MANUALLY REMOVE THE PLEDGET PIECES. SHE CALLED HER DOCTOR WHO ADVISED HER TO STOP USING THE TAMPONS. SHE REPORTED SHE STOPPED USING THE TAMPONS BUT FELT VAGINAL IRRITATION. A FEW DAYS LATER WENT TO URGENT CARE BUT DID NOT RECEIVE ANY MEDICAL TREATMENT. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13157821 ↗
• MalfunctionJan 4, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL MULTIPLE TAMPONS FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE HAD TO MANUALLY REMOVE THE PLEDGET PIECES. SHE CALLED HER DOCTOR WHO ADVISED HER TO STOP USING THE TAMPONS. SHE REPORTED SHE STOPPED USING THE TAMPONS AND A FEW DAYS LATER WENT TO URGENT CARE BUT DID NOT RECEIVE ANY MEDICAL TREATMENT. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13157804 ↗
• MalfunctionJan 4, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL MULTIPLE TAMPONS FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE HAD TO MANUALLY REMOVE THE PLEDGET PIECES. SHE CALLED HER DOCTOR WHO ADVISED HER TO STOP USING THE TAMPONS. SHE REPORTED SHE STOPPED USING THE TAMPONS BUT FELT VAGINAL IRRITATION. A FEW DAYS LATER WENT TO URGENT CARE BUT DID NOT RECEIVE ANY MEDICAL TREATMENT. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13157782 ↗
• MalfunctionJan 4, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL MULTIPLE TAMPONS FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE HAD TO MANUALLY REMOVE THE PLEDGET PIECES. SHE CALLED HER DOCTOR WHO ADVISED HER TO STOP USING THE TAMPONS. SHE REPORTED SHE STOPPED USING THE TAMPONS AND A FEW DAYS LATER WENT TO URGENT CARE BUT DID NOT RECEIVE ANY MEDICAL TREATMENT. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13157773 ↗
• MalfunctionNov 10, 2021Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790953 ↗
• MalfunctionNov 10, 2021Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790943 ↗
• MalfunctionSep 15, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE MANUALLY REMOVED THE REMAINING 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 12478090 ↗
• MalfunctionSep 15, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE MANUALLY REMOVED THE REMAINING 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 12478088 ↗
• MalfunctionSep 15, 2021Component Missing; Component Missing

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED THE STRING WAS MISSING FROM A TAMPON AND SHE HAD TO MANUALLY REMOVE THE PLEDGET FROM HER VAGINAL CAVITY. SHE STATED THAT MANUAL REMOVAL WAS UNCOMFORTABLE. AFTER REMOVAL HER DISCOMFORT RESOLVED. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Discomfort

  MAUDE report 12477999 ↗
• MalfunctionSep 13, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO REMOVE ALL 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 12465717 ↗
• MalfunctionAug 31, 2021Defective Component; Sharp Edges; Defective Component; Sharp Edges

  CONSUMER REPORTED THAT AN UNSPECIFIED AMOUNT OF TAMPONS HAD INSERTION TUBE PETALS THAT WERE BENT OPEN AND FELT VERY SHARP DURING INSERTION. SHE STATED THE APPLICATOR SCRAPED AND PINCHED HER DURING INSERTION BUT THE PAIN SUBSIDED. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Pain

  MAUDE report 12392987 ↗
• MalfunctionAug 31, 2021Defective Component; Sharp Edges; Defective Component; Sharp Edges

  CONSUMER REPORTED THAT AN UNSPECIFIED AMOUNT OF TAMPONS HAD INSERTION TUBE PETALS THAT WERE BENT OPEN AND FELT VERY SHARP DURING INSERTION. SHE STATED THE APPLICATOR SCRAPED AND PINCHED HER DURING INSERTION BUT THE PAIN SUBSIDED. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Pain

  MAUDE report 12392967 ↗
• MalfunctionAug 19, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS UNSURE IF TAMPON PIECES REMAINED INSIDE AND CONSULTED HER DOCTOR OVER CONCERNS ABOUT POSSIBLE INFECTION RESULTING FROM PIECES OF THE PLEDGET REMAINING INSIDE THE VAGINA. THERE WAS NO DIAGNOSIS AND CONSUMER DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12345537 ↗