Poise Pessary (UDI 00036000496215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00036000496215), received between Mar 30, 2021 and Jun 23, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2021Defective Component; Defective Component

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED SHE NOTICED PRIOR TO USE THAT THE STRING WAS TOO SHORT ON HER BLADDER SUPPORT AND SHE DID NOT USE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051901 ↗
• MalfunctionMar 30, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL THE STRING PULLED OUT OF A BLADDER SUPPORT LEAVING THE DEVICE INSIDE HER VAGINAL CAVITY. SHE ATTEMPTED TO MANUALLY REMOVE THE BLADDER SUPPORT AND EXPERIENCED VAGINAL BLEEDING. SHE WAS UNABLE TO REMOVE THE DEVICE ON HER OWN AND THE NEXT MORNING, AFTER SPEAKING WITH HER INSURANCE COMPANY AND HER DOCTOR, SHE WAS REFERRED TO A GYNECOLOGIST. THE GYNECOLOGIST REMOVED THE BLADDER SUPPORT AND CLEANED THE AREA WITH IODINE. CONSUMER WAS PRESCRIBED DOXYCYCLINE AS A PREVENTIVE. SHE EXPERIENCED PAIN AND DISCOMFORT IN HER BELLY BUTTON AREA AFTER THE BLADDER SUPPORT WAS REMOVED. THE BLEEDING, PAIN AND DISCOMFORT RESOLVED A FEW DAYS LATER AND SHE DID NOT RECEIVE ANY ADDITIONAL MEDICAL TREATMENT.

  Patient problems: Discomfort; Intermenstrual Bleeding; Pain

  MAUDE report 11590253 ↗