Poise Pessary (UDI 00036000496185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00036000496185), received between Oct 16, 2020 and Dec 9, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJan 24, 2023Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A BLADDER SUPPORT THE STRING DETACHED IN ONE PIECE. 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 16234121 ↗
• MalfunctionApr 26, 2022Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED PRIOR TO USE SHE NOTICED AN UNSPECIFIED NUMBER OF BLADDER SUPPORT APPLICATORS WITH SLIGHTLY OPEN PETALS. SHE DID NOT USE THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14213599 ↗
• MalfunctionApr 26, 2022Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED UPON INSERTION OF A BLADDER SUPPORT SHE FELT PAIN DUE TO BEING SCRATCHED FROM THE PETALS ON THE APPLICATOR THAT WERE SLIGHTLY OPEN DURING INSERTION. THE PAIN RESOLVED LATER THAT DAY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY SERIOUS ADVERSE HEALTH EFFECTS.

  Patient problems: Pain

  MAUDE report 14213567 ↗
• MalfunctionApr 26, 2022Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED UPON INSERTION OF A BLADDER SUPPORT SHE FELT PAIN DUE TO BEING SCRATCHED FROM THE PETALS ON THE APPLICATOR THAT WERE SLIGHTLY OPEN DURING INSERTION. THE PAIN RESOLVED LATER THAT DAY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY SERIOUS ADVERSE HEALTH EFFECTS.

  Patient problems: Pain

  MAUDE report 14213561 ↗
• MalfunctionOct 19, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656381 ↗
• MalfunctionSep 17, 2021Break; Break

  THE CONSUMER REPORTED THAT THE PESSARY RETRIEVAL STRING WAS SEALED TO THE PRODUCT WRAPPER AND THE STRING BROKE WHILE REMOVING THE PRODUCT FROM ITS PACKAGING. THIS ISSUE WAS OBSERVED PRIOR TO USE; THEREFORE, THE CONSUMER DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487940 ↗
• MalfunctionAug 20, 2021Material Separation; Material Separation

  CONSUMER REPORTED THAT DURING WEAR THE STRING HAD COME OFF OF HER BLADDER SUPPORT LEAVING THE DEVICE INSIDE HER VAGINAL CAVITY. A FEW DAYS LATER SHE WENT TO HER HEALTHCARE PROVIDER FOR REMOVAL OF THE BLADDER SUPPORT. HER DOCTOR REMOVED THE BLADDER SUPPORT AND STATED SHE HAD EXTERNAL AND INTERNAL IRRITATION. CONSUMER DESCRIBED THE IRRITATION AS BURNING WITH BLOODY VAGINAL DISCHARGE. HER DOCTOR PRESCRIBED ORAL ANTIBIOTICS METRONIDAZOLE AND DOXYCYCLINE MONOHYDRATE AND PERFORMED DIAGNOSTIC TESTS. THE DOCTOR STATED HE THOUGHT SHE HAD A VAGINAL INFECTION. SINCE TAKING THE ANTIBIOTICS HER SYMPTOMS IMPROVED AND SHE WAS AWAITING A FOLLOW UP CALL FROM HER DOCTOR.

  Patient problems: Abnormal Vaginal Discharge; Burning Sensation; Skin Inflammation/ Irritation

  MAUDE report 12348276 ↗
• MalfunctionOct 16, 2020Break; Material Separation; Break; Material Separation

  CONSUMER REPORTED THE STRING WAS NOT ATTACHED TO THE PESSARY. SHE DID NOT USE THE AFFECTED PESSARY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10692974 ↗
• MalfunctionOct 16, 2020Break; Material Separation; Break; Material Separation

  THREE COMPANION SAMPLES WERE RETURNED BY THE CONSUMER. THE STRING ON ONE BLADDER SUPPORT WAS IN TWO PIECES, BUT STILL ATTACHED TO THE BLADDER SUPPORT. NO PRODUCT DEFECTS OR ABNORMALITIES WERE OBSERVED WITH THE OTHER TWO BLADDER SUPPORTS.

  Patient problems: Burning Sensation

  MAUDE report 10692935 ↗