Poise Pessary (UDI 00036000496208)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00036000496208), received between Sep 17, 2020 and May 27, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (11 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 22 most recent of 22 reports, 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 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 ↗
• 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 ↗
• MalfunctionMay 15, 2025Material Separation; Material Separation

  NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED THAT AFTER 8 HOURS OF WEARING A PESSARY, SHE ATTEMPTED TO REMOVE IT AND THE STRING SEPARATED FROM IT IN ONE PIECE. SHE WAS UNABLE TO MANUALLY REMOVE THE PESSARY FROM HER VAGINAL CAVITY HERSELF SO SHE WENT TO THE EMERGENCY ROOM WHERE IT WAS SUCCESSFULLY REMOVED. SHE REPORTED EXPERIENCING PAIN DURING HER ATTEMPTED REMOVAL AND CRAMPING AFTER IT WAS REMOVED. SHE HAS RECOVERED AND SHE DID NOT REQUIRE ANY MEDICATION.

  Patient problems: Cramp(s) /Muscle Spasm(s); Foreign Body In Patient; Pain

  MAUDE report 22026324 ↗
• MalfunctionMar 21, 2025Material Separation; Material Separation

  REPORT 3 OF 3. CONSUMER REPORTED THE STRING SEPARATED FROM THE PESSARY PRIOR TO INSERTION INTO HER BODY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663118 ↗
• MalfunctionMar 21, 2025Material Separation; Material Separation

  REPORT 2 OF 3. CONSUMER REPORTED THE STRING SEPARATED FROM THE PESSARY PRIOR TO REMOVAL FROM HER BODY. SHE REPORTED THE PESSARY WAS REMOVED. NO REPORT OF MEDICAL REQUIRED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663110 ↗
• MalfunctionMar 21, 2025Material Separation; Material Separation

  REPORT 1 OF 3. CONSUMER REPORTED THE STRING SEPARATED FROM THE PESSARY PRIOR TO REMOVAL FROM HER BODY. SHE REPORTED THE PESSARY WAS REMOVED. NO REPORT OF MEDICAL REQUIRED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663042 ↗
• MalfunctionJan 14, 2025Product Quality Problem; Product Quality Problem

  REPORT 3 OF 3. CONSUMER REPORTED NOTICING THE PETALS ON A PESSARY APPLICATOR WERE PARTIALLY OPEN PRIOR TO USE. SHE PROCEEDED TO USE THE PESSARY. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21147526 ↗
• MalfunctionJan 14, 2025Product Quality Problem; Product Quality Problem

  REPORT 2 OF 3. CONSUMER REPORTED NOTICING THE PETALS ON A PESSARY APPLICATOR WERE PARTIALLY OPEN PRIOR TO USE. SHE PROCEEDED TO USE THE PESSARY. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21147518 ↗
• MalfunctionJan 14, 2025Product Quality Problem; Product Quality Problem

  REPORT 1 OF 3. CONSUMER REPORTED THAT WITH AN UNSPECIFIED NUMBER OF PESSARIES, SHE NOTICED THE PESSARY APPLICATOR PETALS WERE OPEN BEFORE USE. WITH SOME OF THESE PESSARIES SHE PROCEEDED TO USE THEM AND SOMETIMES IT CAUSED PAIN AS SHE INSERTED IT INTO HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Pain

  MAUDE report 21147487 ↗
• MalfunctionSep 19, 2023Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A BLADDER SUPPORT, THE STRING SEPARATED FROM THE PESSARY. SHE MANUALLY REMOVED THE PESSARY FROM HER VAGINAL CAVITY WITH A PLIERS. FOLLOWING REMOVAL, SHE REPORTED THAT SHE EXPERIENCED SOME MINOR BLEEDING THAT RESOLVED BY THE FOLLOWING DAY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Genital Bleeding

  MAUDE report 17777333 ↗
• MalfunctionJun 28, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL THE STRING PULLED OUT OF A BLADDER SUPPORT LEAVING THE PESSARY INSIDE HER VAGINAL CAVITY. SHE WENT TO ER FOR REMOVAL OF THE PESSARY. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS AND DID NOT REQUIRE ANY FOLLOW-UP MEDICAL VISITS.

  Patient problems: Foreign Body In Patient

  MAUDE report 14848200 ↗
• MalfunctionNov 8, 2021Difficult to Remove; Difficult to Remove

  CONSUMER REPORTED SHE HAD PAIN WITH THE INSERTION OF A BLADDER SUPPORT AND ATTEMPTED TO REMOVE IT RIGHT AWAY BUT COULD NOT FIND THE STRING TO REMOVE IT. THE BLADDER SUPPORT REMAINED INSIDE HER VAGINAL CAVITY FOR TWO DAYS. SHE STATED SHE HAD BEEN TRYING TO REMOVE IT HERSELF AND COULD FEEL THE BLADDER SUPPORT INSIDE BUT COULD NOT GET A GRIP ON IT TO REMOVE IT. SHE CALLED AND SPOKE WITH A NURSE WHO TOLD HER SHE COULD NOT DO ANYTHING FOR HER WITHOUT A DOCTOR'S ORDER. DURING THE LAST CONTACT WITH THE CONSUMER, SHE STATED SHE WAS GETTING READY TO GO TO THE ER TO HAVE THE IMPRESSA REMOVED. SHE REPORTED SHE WAS EXPERIENCING ABDOMINAL PAIN AND CRAMPING IN HER BACK. 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: Abdominal Pain; Cramp(s) /Muscle Spasm(s)

  MAUDE report 12771475 ↗
• MalfunctionSep 17, 2020Break; Break

  CONSUMER REPORTED UPON REMOVAL THE STRING BROKE LEAVING THE PESSARY INSIDE HER VAGINAL CAVITY. SHE MANUALLY REMOVED THE PESSARY AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10550762 ↗