Poise Pessary (UDI 00036000496192)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00036000496192), received between Feb 11, 2021 and Aug 19, 2025 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2025Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A PESSARY; THE STRING SEPARATED FROM IT IN ONE PIECE. SHE MANUALLY REMOVED THE PESSARY FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841564 ↗
• MalfunctionJan 9, 2025Material Separation; Material Separation

  CONSUMER REPORTED THAT PRIOR TO USE OF A PESSARY, SHE PULLED ON THE STRING AND IT DETACHED. THERE WAS NO HARM REPORTED AS SHE DID NOT USE THE PESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111344 ↗
• MalfunctionDec 30, 2024Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A PESSARY, THE STRING SEPARATED FROM THE PESSARY. SHE WAS NOT ABLE TO MANUALLY REMOVE THE PESSARY FROM HER VAGINAL CAVITY SO APPROXIMATELY ONE HOUR LATER SHE HAD IT REMOVED BY A DOCTOR. SHE EXPERIENCED MINOR INTERMITTENT BLEEDING. SHE DID NOT REPORT ALLEGATIONS OF A SERIOUS ADVERSE EVENT OR HARM. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S USE OF THE PRODUCT AND OUTCOME; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Genital Bleeding

  MAUDE report 21044543 ↗
• MalfunctionAug 12, 2024Material Separation; Material Separation

  REPORT 2 OF 2. CONSUMER REPORTED UPON ATTEMPTED REMOVAL OF A PESSARY, THE STRING WAS SEPARATED FROM THE BLADDER SUPPORT. SHE WAS UNSURE IF IT SEPARATED WHEN SHE PULLED ON IT FOR REMOVAL OR IF IT SEPARATED DURING WEAR. SHE MANUALLY REMOVED THE BLADDER SUPPORT 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 19963419 ↗
• MalfunctionAug 12, 2024Material Separation; Material Separation

  REPORT 1 OF 2. CONSUMER REPORTED UPON ATTEMPTED REMOVAL OF A PESSARY, THE STRING WAS DETACHED FROM THE BLADDER SUPPORT. SHE MANUALLY REMOVED THE BLADDER SUPPORT FROM HER VAGINAL CAVITY. SHE DID NOT REQUIRE MEDICAL ASSISTANCE AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19963108 ↗
• MalfunctionNov 17, 2023Difficult to Remove; Difficult to Remove

  REPORT 4 OF 4. CONSUMER REPORTED SHE OPENED A PESSARY FOR USE AND THE STRING WAS TOO SHORT. SHE DID NOT USE THE PESSARY AND DISCARDED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159171 ↗
• MalfunctionNov 17, 2023Difficult to Remove; Difficult to Remove

  REPORT 3 OF 4. CONSUMER REPORTED SHE OPENED A PESSARY FOR USE AND THE STRING WAS TOO SHORT. SHE DID NOT USE THE PESSARY AND DISCARDED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159097 ↗
• MalfunctionNov 17, 2023Difficult to Remove; Difficult to Remove

  REPORT 2 OF 4. CONSUMER REPORTED SHE OPENED A PESSARY FOR USE AND THE STRING WAS TOO SHORT. SHE DID NOT USE THE PESSARY AND DISCARDED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159051 ↗
• MalfunctionNov 17, 2023Difficult to Remove; Difficult to Remove

  REPORT 1 OF 4. CONSUMER REPORTED SHE OPENED A PESSARY FOR USE AND THE STRING WAS TOO SHORT. SHE DID NOT USE THE PESSARY AND DISCARDED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158972 ↗
• MalfunctionFeb 11, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL THE STRING PULLED OUT OF THE BLADDER SUPPORT LEAVING THE DEVICE INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE DEVICE AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11318090 ↗
• MalfunctionFeb 11, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL THE STRING PULLED OUT OF THE BLADDER SUPPORT LEAVING THE DEVICE INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE DEVICE AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11318063 ↗