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MILEX MXPSH2-3/4Recalls & reported problems

Coopersurgical, Inc. · Shaatz Folding Pessary; 2 3/4" (70mm) · Class 2

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 00888937009132), received between Dec 4, 2020 and Dec 4, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Too Rigid or Stiff1

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.

  • MalfunctionDec 4, 2020Material Too Rigid or Stiff

    REPORT STATED: "THE CUSTOMER HAS ISSUED A CUSTOMER DISSATISFACTION COMPLAINT SOME TIME AGO SAYING THE PESSARIES ARE TOO STIFF". 1216677-2020-00285-1 MXPSH2-3-4 SHAATZ PESSARY 2-3-4 E-(B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10949683 ↗

Other Pessary, Vaginal devices

All Pessary, Vaginal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.