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2026 data FDA MAUDE openFDA FDA Class II

Cup, Menstrual

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 §884.5400 (Obstetrics/Gynecology panel).

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FDA MAUDE casebook

openFDA event book Cup, Menstrual LIGHT-BOOK · MAUDE

#858 of 1000 · 553 reports · 1997–2026

  • BOOK 553 reports
  • RANK #858 of 1000
  • DEATH 0 death-typed
  • INJ 373 injury-typed
  • MALF 169 malfunction
  • SPAN 1997–2026
  • PEAK 2020: 220
  • PHOTO Applicator

Nearest event-volume peer: Applicator, Absorbent Tipped, Non-Sterile (1 report gap)

Cup, Menstrual sits #858 of 1000 among tracked device types with 553 MAUDE reports spanning 1997–2026. 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 → · Similar-volume device →

Injury-coded reports run above the device-type norm

Cup, Menstrual carries 67.5% INJURY-coded reports, 37.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 67.5% corpus 30.3% · above corpus mean (+37.2 pp)
  • MALF 30.6% corpus 64.8% · below corpus mean (-34.3 pp)

Lead product-problem code Difficult to Remove is 46% of coded problems · Top event location I is 51% of location-tagged rows .

Cup, Menstrual in the event-volume neighbourhood

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

reports

What this shows Cup, Menstrual carries 553 MAUDE reports, ranked #858 of 1000.

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

Event Types

Injury 373 (67.5%)
Malfunction 169 (30.6%)
Other 11 (2.0%)

Patient Outcomes

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

Required Intervention 338 (58.6%)
Other 122 (21.1%)
64 (11.1%)
Hospitalization 19 (3.3%)
R 16 (2.8%)
Disability 6 (1.0%)
L 4 (0.7%)
O 3 (0.5%)
H 2 (0.3%)
S 2 (0.3%)
Life Threatening 1 (0.2%)

Top Product Problems

Difficult to Remove 308
Patient Device Interaction Problem 234
Adverse Event Without Identified Device or Use Problem 34
Insufficient Device Problem Information 15
Patient-Device Incompatibility 14
Break 10
Suction Problem 9
Device-Device Incompatibility 7
Appropriate Device Problem Term/Code Not Available 6
Reaction 6
Compatibility Problem 5
Device Dislodged or Dislocated 5
Expulsion 4
Entrapment of Device 2
Improper or Incorrect Procedure or Method 2
Inadequacy of Device Shape and/or Size 2
Inadequate Instructions for Non-Healthcare Professional 2
Labelling, Instructions for Use or Training Problem 2
Migration or Expulsion of Device 2
Product Quality Problem 2

Yearly Trend

97
1997: 6
98
1998: 4
00
2000: 4
01
2001: 1
03
2003: 1
04
2004: 1
05
2005: 3
06
2006: 1
08
2008: 1
09
2009: 1
10
2010: 1
12
2012: 2
14
2014: 2
15
2015: 2
16
2016: 1
17
2017: 4
18
2018: 1
19
2019: 22
20
2020: 220
21
2021: 40
22
2022: 26
23
2023: 133
24
2024: 29
25
2025: 35
26
2026: 12

Reports fell to 35 in 2025, down from an average of 81 in the two years before.

Related Entities for Cup, Menstrual

Event Locations

I 280 (50.6%)
244 (44.1%)
HOME 12 (2.2%)
NO INFORMATION 8 (1.4%)
UNKNOWN 4 (0.7%)
HOSPITAL 3 (0.5%)
INVALID DATA 2 (0.4%)

Nationwide devices with a comparable report-volume footprint

Cup, Menstrual carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (553 here).

Applicator, Absorbent Tipped, Non-Sterile 552 Chair, Positioning, Electric 554 Prosthesis 555 Kit, Surgical Instrument, Disposable 550

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Cup, Menstrual 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 Cup, Menstrual; 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.