PoiseRecalls & reported problems across all models

We found 6 models of Poise by Kimberly-Clark Global Sales, Inc. in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Sep 17, 2020 and May 27, 2026 — classified as 52 malfunctions.

The most frequently reported specific device problem is “Material Separation” (23 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Poise problems

Poise models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Poise Pessary

  PESSARY, VAGINAL
  22 reports
• Poise Pessary

  PESSARY, VAGINAL
  13 reports
• Poise Pessary

  PESSARY, VAGINAL
  11 reports
• Poise Pessary

  PESSARY, VAGINAL
  3 reports
• Poise Pessary

  PESSARY, VAGINAL
  2 reports
• Poise Pessary

  PESSARY, VAGINAL
  1 report

Recent Poise adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Material Separation

  REPORT 2 OF 2. CONSUMER REPORTED DURING USE OF A PESSARY, THE STRING SEPARATED FROM THE PESSARY. SHE MANUALLY REMOVED THE PESSARY FROM HER VAGINAL CAVITY. SHE REPORTED THE PESSARY SCRAPED HER VAGINAL CAVITY UPON REMOVAL WHICH RESULTED IN PAIN AND BLEEDING. CONSUMER CONSULTED HER GYNECOLOGIST AND WAS ADVISED TO USE AN OTC TOPICAL MEDICATION, A&D OINTMENT. SHE HAS SINCE IMPROVED.

  Patient problems: Abrasion; Genital Bleeding; Pain

  MAUDE report 25302374 ↗
• MalfunctionMay 27, 2026Material Separation

  REPORT 1 OF 2. CONSUMER REPORTED UPON ATTEMPTED INSERTION OF A PESSARY, THE STRING DETACHED. SHE DID NOT CONTINUE TO USE THAT PESSARY. 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 25302313 ↗
• MalfunctionDec 9, 2025Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A PESSARY, THE STRING SEPARATED. SHE MANUALLY REMOVED THE PESSARY FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT REPORT ANY SERIOUS ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759881 ↗
• MalfunctionDec 1, 2025Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A PESSARY, THE STRING SEPARATED FROM THE BLADDER SUPPORT. SHE WAS UNABLE TO MANUALLY REMOVE IT SO THE NEXT DAY SHE SOUGHT MEDICAL FOR REMOVAL. SHE REPORTED EXPERIENCING SOME TEMPORARY DISCOMFORT WHICH HAS RESOLVED. SHE DID NOT EXPERIENCE ANY SERIOUS ADVERSE EFFECTS.

  Patient problems: Discomfort; Foreign Body In Patient

  MAUDE report 23679931 ↗
• MalfunctionNov 4, 2025Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED THAT THE APPLICATOR PETALS OF AN UNSPECIFIED NUMBER OF PESSARIES WERE PARTIALLY OPEN AND DURING INSERTION SHE WAS PINCHED AND NOTICED BLOOD AND A CUT. SHE HAS IMPROVED. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT REPORT ANY SERIOUS ADVERSE HEALTH EFFECTS.

  Patient problems: Abrasion; Genital Bleeding

  MAUDE report 23464875 ↗
• MalfunctionOct 23, 2025Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED VIA EMAIL THAT WITH AN UNSPECIFIED NUMBER OF PESSARIES, SHE NOTICED THE APPLICATOR TIP WAS OPEN PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366721 ↗
• MalfunctionOct 23, 2025Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED VIA EMAIL THAT WITH AN UNSPECIFIED NUMBER OF PESSARIES, SHE NOTICED THE APPLICATOR TIP WAS OPEN PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366712 ↗
• MalfunctionOct 15, 2025Product Quality Problem; Product Quality Problem

  REPORT 4 OF 4. NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED THE PESSARY APPLICATOR WAS ALREADY OPENED AND PUSHED OUT PRIOR TO USE. SHE DID NOT USE THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285220 ↗
• MalfunctionOct 15, 2025Product Quality Problem; Product Quality Problem

  REPORT 1 OF 4. NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED THE PESSARY APPLICATOR WAS ALREADY OPENED AND PUSHED OUT PRIOR TO USE. SHE DID NOT USE THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285163 ↗
• MalfunctionOct 15, 2025Product Quality Problem; Product Quality Problem

  REPORT 3 OF 4. NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED THE PESSARY APPLICATOR WAS ALREADY OPENED AND PUSHED OUT PRIOR TO USE. SHE DID NOT USE THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285042 ↗
• MalfunctionOct 15, 2025Product Quality Problem; Product Quality Problem

  REPORT 2 OF 4. NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED THE PESSARY APPLICATOR WAS ALREADY OPENED AND PUSHED OUT PRIOR TO USE. SHE DID NOT USE THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23284657 ↗
• MalfunctionOct 15, 2025Product Quality Problem; Product Quality Problem

  REPORT 3 OF 4. NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED THE PESSARY APPLICATOR WAS ALREADY OPENED AND PUSHED OUT PRIOR TO USE. SHE DID NOT USE THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280101 ↗
• MalfunctionOct 15, 2025Product Quality Problem; Product Quality Problem

  REPORT 4 OF 4. NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED THE PESSARY APPLICATOR WAS ALREADY OPENED AND PUSHED OUT PRIOR TO USE. SHE DID NOT USE THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280056 ↗
• MalfunctionOct 15, 2025Product Quality Problem; Product Quality Problem

  REPORT 1 OF 4. NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED THE PESSARY APPLICATOR WAS ALREADY OPENED AND PUSHED OUT PRIOR TO USE. SHE DID NOT USE THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279935 ↗
• MalfunctionOct 15, 2025Product Quality Problem; Product Quality Problem

  REPORT 2 OF 4. NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED THE PESSARY APPLICATOR WAS ALREADY OPENED AND PUSHED OUT PRIOR TO USE. SHE DID NOT USE THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279895 ↗

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