Poise Pessary (UDI 00036000496239)Recalls & reported problems
Kimberly-Clark Global Sales, Inc. · POISE IMPRESSA SIZE 1 BLADDER SUPPORT DEVICE · Class 2
All models of Poise (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00036000496239), received between Nov 21, 2022 and Jun 13, 2023 — classified as 3 malfunctions.
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 18, 2026.
Most reported problems
Device problems
- Break1
- Material Separation1
- Product Quality Problem1
Patient problems
- Abrasion1
- Cramp(s) /Muscle Spasm(s)1
- Genital Bleeding1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2023Break; Break
CONSUMER REPORTED THAT SHE OPENED THE INDIVIDUAL WRAPPER OF A PESSARY WITH A PAIR OF SCISSORS AND PRIOR TO INSERTION OF IT INTO HER VAGINAL CAVITY, SHE NOTICED THE STRING WAS BROKEN INTO TWO PIECES. ONE PIECE OF STRING WAS ATTACHED TO THE PESSARY AND THE OTHER WAS LOOSE AND FELL TO THE GROUND WHEN SHE OPENED THE WRAPPER. SHE DID NOT USE THE PESSARY AND SHE DISCARDED IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17117887 ↗MalfunctionNov 28, 2022Product Quality Problem; Product Quality Problem
CONSUMER REPORTED SHE INSERTED A BLADDER SUPPORT AND THE PETALS ON THE APPLICATOR WERE SLIGHTLY OPEN WHICH PINCHED AND SCRATCHED HER VAGINALLY. SHE FULLY RECOVERED AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.
Patient problems: Abrasion
MAUDE report 15870106 ↗MalfunctionNov 21, 2022Material Separation; Material Separation
THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED AFTER INSERTION OF A BLADDER SUPPORT SHE NOTICED THE STRING WAS MISSING. THE NEXT DAY SHE WENT TO HER DOCTOR WHO DID AN INTERNAL VAGINAL EXAM AND NO BLADDER SUPPORT WAS LOCATED INSIDE. SHE EXPERIENCED BLEEDING DURING THE EXAM AND HER PROVIDER ADVISED USING A HEATING PAD. SHE ALSO EXPERIENCED CRAMPING WHICH HAS IMPROVED.
Patient problems: Cramp(s) /Muscle Spasm(s); Genital Bleeding
MAUDE report 15839561 ↗
Other PESSARY, VAGINAL devices
- Milex MXPCON06Coopersurgical, Inc. · Pessary, Vaginal1 recall0 reports
- Poise PessaryKimberly-Clark Global Sales, Inc. · PESSARY, VAGINAL22 reports
- Poise PessaryKimberly-Clark Global Sales, Inc. · PESSARY, VAGINAL13 reports
- Poise PessaryKimberly-Clark Global Sales, Inc. · PESSARY, VAGINAL11 reports
- Milex MXPGE2-1/2Coopersurgical, Inc. · Pessary, Vaginal2 reports
- Milex MXPGE2-1/4Coopersurgical, Inc. · Pessary, Vaginal1 death2 reports
- Poise PessaryKimberly-Clark Global Sales, Inc. · PESSARY, VAGINAL2 reports
- Revive 0025Rinovum Subsidiary 2, LLC · Pessary, Vaginal1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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