2026 data FDA MAUDE openFDA FDA Class II

Tampon, Menstrual, Unscented

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 §884.5470 (Obstetrics/Gynecology panel).

FDA MAUDE casebook

openFDA event book Tampon, Menstrual, Unscented MID-BOOK · MAUDE

#195 of 1000 · 11,865 reports · 1994–2026

  • BOOK 11,865 reports
  • RANK #195 of 1000
  • DEATH 13 death-typed
  • INJ 1,086 injury-typed
  • MALF 10,654 malfunction
  • SPAN 1994–2026
  • PEAK 2019: 3,034
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Coronary, Atherectomy (42 report gap)

Tampon, Menstrual, Unscented sits #195 of 1000 among tracked device types with 11,865 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 → · Similar-volume device →

Malfunction reports run above the device-type norm

Tampon, Menstrual, Unscented carries 89.8% MALFUNCTION-coded reports, 25.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 9.2% corpus 30.3% · below corpus mean (-21.1 pp)
  • MALF 89.8% corpus 64.8% · above corpus mean (+25.0 pp)

Lead product-problem code Material Separation is 43% of coded problems · Top event location I is 54% of location-tagged rows .

Tampon, Menstrual, Unscented in the event-volume neighbourhood

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

reports

What this shows Tampon, Menstrual, Unscented carries 11,865 MAUDE reports, ranked #195 of 1000.

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

Event Types

Malfunction 10,654 (89.8%)
Injury 1,086 (9.2%)
Other 89 (0.8%)
23 (0.2%)
Death 13 (0.1%)

Patient Outcomes

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

10,704 (87.9%)
Required Intervention 440 (3.6%)
Other 344 (2.8%)
Hospitalization 272 (2.2%)
L 123 (1.0%)
R 113 (0.9%)
O 62 (0.5%)
Life Threatening 46 (0.4%)
S 29 (0.2%)
Disability 22 (0.2%)
Death 14 (0.1%)
H 12 (0.1%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Material Separation 5,522
Insufficient Device Problem Information 1,953
No Apparent Adverse Event 987
Break 867
Adverse Event Without Identified Device or Use Problem 855
Difficult to Remove 625
Component Missing 388
Product Quality Problem 323
Detachment Of Device Component 286
Material Fragmentation 278
Unknown (for use when the device problem is not known) 136
Material Integrity Problem 84
Unraveled Material 81
Material Disintegration 68
Reaction 60
Device Operates Differently Than Expected 53
Sharp Edges 52
Patient-Device Incompatibility 48
Design/structure problem 45
Component Falling 30

Yearly Trend

94
1994: 8
95
1995: 1
96
1996: 53
97
1997: 72
98
1998: 108
99
1999: 57
00
2000: 52
01
2001: 35
02
2002: 39
03
2003: 45
04
2004: 31
05
2005: 34
06
2006: 23
07
2007: 38
08
2008: 31
09
2009: 30
10
2010: 138
11
2011: 291
12
2012: 415
13
2013: 259
14
2014: 167
15
2015: 132
16
2016: 101
17
2017: 194
18
2018: 363
19
2019: 3,034
20
2020: 1,714
21
2021: 1,403
22
2022: 1,055
23
2023: 702
24
2024: 534
25
2025: 454
26
2026: 252

Reports in 2025 (454) held close to the prior two-year average of 618.

Related Entities for Tampon, Menstrual, Unscented

Event Locations

I 6,387 (53.8%)
4,580 (38.6%)
OTHER 292 (2.5%)
HOME 284 (2.4%)
NO INFORMATION 139 (1.2%)
INVALID DATA 91 (0.8%)
UNKNOWN 83 (0.7%)
HOSPITAL 7 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Tampon, Menstrual, Unscented: 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 (11,865 here).

Similar death-typed counts

Nearest other device types by death-typed report count (13 here), distinct from the volume row.

Disclaimer: MAUDE figures for Tampon, Menstrual, Unscented 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 Tampon, Menstrual, Unscented; 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.