U by Kotex Tampon (UDI 00036000159509)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00036000159509), received between Oct 21, 2020 and Mar 1, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2024Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF AN UNSPECIFIED NUMBER OF SUPER ABSORBENCY TAMPONS, THE STRING SEPARATED FROM THE PLEDGET. SHE MANUALLY REMOVED THE PLEDGET FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18816539 ↗
• MalfunctionJan 5, 2024Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECE FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18453143 ↗
• MalfunctionSep 20, 2023Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. SHE RECEIVED ASSISTANCE FROM HER MOTHER TO MANUALLY REMOVE THE REMAINING PLEDGET PIECES FROM HER VAGINAL CAVITY. SHE REPORTED SHE WENT TO URGENT CARE AND IT WAS CONFIRMED THAT NO PIECES OF PLEDGET REMAINED INSIDE OF HER. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785852 ↗
• MalfunctionMar 3, 2023Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON THAT WAS ON THE DRIER SIDE, THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECE FROM THE EDGE OF HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478104 ↗
• MalfunctionMar 3, 2023Material Separation; Material Separation

  REPORT 2 OF 3. CONSUMER REPORTED UPON REMOVAL OF A TAMPON THAT WAS ON THE DRIER SIDE, THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECE FROM THE EDGE OF HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478094 ↗
• MalfunctionDec 15, 2022Material Separation; Material Separation

  REPORT 2 OF 2. CONSUMER REPORTED THAT UPON REMOVAL OF AN UNSPECIFIED NUMBER OF SUPER ABSORBENCY TAMPONS THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECES FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15991053 ↗
• MalfunctionDec 15, 2022Difficult to Remove; Difficult to Remove

  CONSUMER REPORTED PRIOR TO USE THE STRING ON A TAMPON APPEARED TO BE WRAPPED AROUND THE PLEDGET ONCE. SHE USED THIS TAMPON AND UPON REMOVAL THE STRING WAS STUCK TO SOMETHING, SHE SAID POSSIBLY HER IUD BUT SHE WAS NOT SURE. SHE HAD HELP FROM HER BOYFRIEND TO MANUALLY PULL THE PLEDGET OUT OF HER VAGINAL CAVITY ENOUGH TO BE ABLE TO CUT THE STRING WHICH ALLOWED HER TO THEN BE ABLE TO REMOVE THE STRING AS WELL. SHE EXPERIENCED PAIN DURING REMOVAL WHICH RESOLVED AFTER TAKING OTC MIDOL OR IBUPROFEN. SHE DID NOT SEEK MEDICAL ATTENTION FOR THIS INCIDENT AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Pain

  MAUDE report 15987233 ↗
• MalfunctionDec 13, 2022Material Separation; Material Separation

  CONSUMER REPORTED THAT UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS, THE STRINGS SEPARATED LEAVING THE PLEDGETS INSIDE HER VAGINAL CAVITY. SHE MANUALLY REMOVED THE PLEDGETS. SHE ALSO REPORTED SHE RECEIVED LACERATIONS UPON INSERTION OF AN UNSPECIFIED NUMBER OF TAMPONS. SHE USED OVER THE COUNTER VASELINE FOR THE LACERATIONS AND IS IMPROVING. THE CONSUMER DID NOT SEEK MEDICAL ATTENTION FOR EITHER OF THE REPORTED ISSUES AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Laceration(s)

  MAUDE report 15970351 ↗
• MalfunctionAug 18, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS UNSURE IF PLEDGET PIECES REMAINED INSIDE AND CONSULTED HER HEALTHCARE PROVIDER OVER THE PHONE. SHE WAS TOLD TO MONITOR FOR SYMPTOMS. SHE DID NOT SEEK ADDITIONAL MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS. SHE BELIEVED NO PLEDGET PIECES REMAINED INSIDE HER VAGINAL CAVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338048 ↗
• MalfunctionOct 23, 2020Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10730706 ↗
• MalfunctionOct 23, 2020Break; Break

  CONSUMER REPORTED UPON REMOVAL THE STRING BROKE AND SHE HAD TO MANUALLY REMOVE THE TAMPON PLEDGET FROM HER VAGINAL CAVITY. SHE WAS ABLE TO REMOVE THE PLEDGET IN ONE PIECE, AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10730682 ↗
• MalfunctionOct 23, 2020Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10730651 ↗
• MalfunctionOct 23, 2020Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10730643 ↗
• MalfunctionOct 23, 2020Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10730636 ↗
• MalfunctionOct 23, 2020Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10730619 ↗
• MalfunctionOct 21, 2020Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL THE STRING SEPARATED FROM THE TAMPON AND SHE HAD TO MANUALLY REMOVE THE TAMPON PLEDGET FROM HER VAGINAL CAVITY. SHE WAS ABLE TO REMOVE THE PLEDGET IN ONE PIECE AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10710723 ↗