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Poise Pessary (UDI 00036000465600)Recalls & reported problems

Kimberly-Clark Global Sales, Inc. · POISE IMPRESSA SIZE 3 BLADDER SUPPORT DEVICE · Class 2

All models of Poise (6)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00036000465600), received between Jun 11, 2021 and Jun 11, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 11, 2021Break; Break

    CONSUMER REPORTED THAT AFTER SHE WORE A BLADDER SUPPORT FOR APPROXIMATELY 12 HOURS, THE STRING BROKE OFF DURING REMOVAL LEAVING THE PESSARY INSIDE HER VAGINAL CAVITY. SHE WAS UNABLE TO MANUALLY REMOVE THE PESSARY. SHE STATED THAT HER HUSBAND WHO IS A NURSE USED FORCEPS TO REMOVE THE BLADDER SUPPORT. SHE DID NOT SEEK ANY ADDITIONAL MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11985016 ↗

Other PESSARY, VAGINAL devices

All PESSARY, VAGINAL devices →

Sources and updates

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