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2026 data FDA MAUDE openFDA FDA Class II

Pessary, Vaginal

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §884.3575 (Obstetrics/Gynecology panel).

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FDA MAUDE casebook

openFDA event book Pessary, Vaginal LIGHT-BOOK · MAUDE

#849 of 1000 · 575 reports · 1994–2026

  • BOOK 575 reports
  • RANK #849 of 1000
  • DEATH 1 death-typed
  • INJ 41 injury-typed
  • MALF 517 malfunction
  • SPAN 1994–2026
  • PEAK 2020: 401
  • PHOTO Lead

Nearest event-volume peer: Lead, Atomic Absorption (0 report gap)

Pessary, Vaginal sits #849 of 1000 among tracked device types with 575 MAUDE reports spanning 1994–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Pessary, Vaginal carries 89.9% MALFUNCTION-coded reports, 25.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 7.1% corpus 30.3% · below corpus mean (-23.2 pp)
  • MALF 89.9% corpus 64.8% · above corpus mean (+25.1 pp)

Lead product-problem code Material Separation is 32% of coded problems · Lead manufacturer UNKNOWN accounts for 44% of manufacturer-tagged reports · Top event location I is 72% of location-tagged rows .

Pessary, Vaginal in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Pessary, Vaginal carries 575 MAUDE reports, ranked #849 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 517 (89.9%)
Injury 41 (7.1%)
Other 12 (2.1%)
4 (0.7%)
Death 1 (0.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

451 (77.8%)
Other 84 (14.5%)
Required Intervention 34 (5.9%)
Disability 3 (0.5%)
H 2 (0.3%)
R 2 (0.3%)
D 1 (0.2%)
L 1 (0.2%)
Hospitalization 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Material Separation 192
Break 101
Component Missing 67
Difficult to Remove 58
Material Too Rigid or Stiff 44
Product Quality Problem 44
Difficult to Insert 17
Use of Device Problem 11
Adverse Event Without Identified Device or Use Problem 9
Sharp Edges 9
Insufficient Device Problem Information 8
Unknown (for use when the device problem is not known) 8
Patient-Device Incompatibility 7
Device, removal of (non-implant) 4
Material Discolored 4
Material Integrity Problem 4
Material Erosion 3
Other (for use when an appropriate device code cannot be identified) 3
Output Problem 3
Reaction 3

Yearly Trend

94
1994: 1
96
1996: 1
97
1997: 2
99
1999: 1
00
2000: 2
01
2001: 1
04
2004: 13
05
2005: 5
07
2007: 4
08
2008: 2
09
2009: 2
11
2011: 1
12
2012: 2
14
2014: 5
15
2015: 1
16
2016: 6
17
2017: 5
18
2018: 3
19
2019: 15
20
2020: 401
21
2021: 24
22
2022: 14
23
2023: 12
24
2024: 6
25
2025: 39
26
2026: 7

Reports rose to 39 in 2025, up from an average of 9 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Pessary, Vaginal

Top Manufacturers

UNKNOWN 4
UNK 3
SMITHS MEDICAL ASD, INC. 2

Event Locations

I 416 (72.3%)
152 (26.4%)
NO INFORMATION 3 (0.5%)
HOSPITAL 1 (0.2%)
INVALID DATA 1 (0.2%)
OTHER 1 (0.2%)
UNKNOWN 1 (0.2%)

Compare UNKNOWN vs UNK →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Pessary, Vaginal: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (575 here).

Lead, Atomic Absorption 575 Injector, Contrast Medium, Automatic 576 Sealant, Dural 576 Drug-Eluting Percutaneous Transluminal Coro… 578

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Pessary, Vaginal are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Pessary, Vaginal; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.