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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Pessary, Vaginal LIGHT-BOOK · MAUDE

#827 of 1000 · 571 reports · 1994–2026

  • BOOK 571 reports
  • RANK #827 of 1000
  • DEATH 1 death-typed
  • INJ 39 injury-typed
  • MALF 515 malfunction
  • SPAN 1994–2026
  • PEAK 2020: 401
  • PHOTO Calibrator

Nearest event-volume peer: Calibrator, Multi-Analyte Mixture (2 report gap)

Pessary, Vaginal sits #827 of 1000 among tracked device types with 571 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 6.8% corpus 30.4% · below corpus mean (-23.6 pp)
  • MALF 90.2% corpus 64.5% · above corpus mean (+25.7 pp)

Lead product-problem code Material Separation is 34% of coded problems · Lead manufacturer UNKNOWN accounts for 50% of manufacturer-tagged reports · Top event location I is 73% 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 571 MAUDE reports, ranked #827 of 1000.

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

Event Types

Malfunction 515 (90.2%)
Injury 39 (6.8%)
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.

448 (77.8%)
Other 83 (14.4%)
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 190
Break 98
Component Missing 67
Difficult to Remove 47
Product Quality Problem 44
Material Too Rigid or Stiff 43
Difficult to Insert 16
Use of Device Problem 11
Sharp Edges 9
Adverse Event Without Identified Device or Use Problem 8
Insufficient Information 6
Patient-Device Incompatibility 6
Material Integrity Problem 4
Material Discolored 3
Material Erosion 3
Output Problem 3
Defective Device 2
Device Dislodged or Dislocated 2
Device Operates Differently Than Expected 2
Inadequacy of Device Shape and/or Size 2

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: 3

Related Entities for Pessary, Vaginal

Top Manufacturers

UNKNOWN 4
SMITHS MEDICAL ASD, INC. 2
UNK 2

Event Locations

I 416 (72.9%)
148 (25.9%)
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 SMITHS MEDICAL ASD, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Pessary, Vaginal, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (571 here).

Calibrator, Multi-Analyte Mixture 573 Prosthesis 573 Device, Anastomotic, Microvascular 568 Mouthguard, Prescription 568

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.