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Milex MXPGE2-1/2Recalls & reported problems

Coopersurgical, Inc. · Gellhorn Flexible Pessary; 2 1/2" (64mm) · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888937006728), received between Nov 23, 2020 and Aug 24, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Too Rigid or Stiff2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionAug 24, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

    HEALTHCARE PROFESSIONAL REPORTED VIA COMPANY REPRESENTATIVE "HAVING STIFFNESS ISSUES WITH OUR GELLHORNS."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17612496 ↗
  • MalfunctionNov 23, 2020Material Too Rigid or Stiff

    THE PESSARY IS TOO STIFF. GELLHORN PESS FLEX 2 1-2 MXPGE2 1-2 (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10885481 ↗

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.