2026 data FDA MAUDE openFDA FDA Class III

Transcervical Contraceptive Tubal Occlusion Device

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 III (highest risk, premarket approval required), regulated under 21 CFR §884.5380 (Obstetrics/Gynecology panel).

FDA MAUDE casebook

openFDA event book Transcervical Contraceptive Tubal Occlusion… MID-BOOK · MAUDE

#52 of 1000 · 74,502 reports · 1994–2026

  • BOOK 74,502 reports
  • RANK #52 of 1000
  • DEATH 137 death-typed
  • INJ 72,854 injury-typed
  • MALF 1,077 malfunction
  • SPAN 1994–2026
  • PEAK 2020: 16,135
  • PHOTO Glucose Dehydrogenase

Nearest event-volume peer: Glucose Dehydrogenase, Glucose (297 report gap)

Transcervical Contraceptive Tubal Occlusion Device sits #52 of 1000 among tracked device types with 74,502 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 →

Injury-coded reports run above the device-type norm

Transcervical Contraceptive Tubal Occlusion… carries 97.8% INJURY-coded reports, 67.5pp 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 97.8% corpus 30.3% · above corpus mean (+67.5 pp)
  • MALF 1.4% corpus 64.8% · below corpus mean (-63.4 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 50% of coded problems · Lead manufacturer BAYER PHARMA AG accounts for 87% of manufacturer-tagged reports · Top event location I is 79% of location-tagged rows .

Transcervical Contraceptive Tubal Occlusion… in the event-volume neighbourhood

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

reports

What this shows Transcervical Contraceptive Tubal Occlusion Device carries 74,502 MAUDE reports, ranked #52 of 1000.

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

Event Types

Injury 72,854 (97.8%)
Malfunction 1,077 (1.4%)
Other 238 (0.3%)
196 (0.3%)
Death 137 (0.2%)

Patient Outcomes

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

Other 56,957 (41.7%)
R 52,971 (38.7%)
Required Intervention 8,430 (6.2%)
Hospitalization 5,901 (4.3%)
O 5,577 (4.1%)
S 2,793 (2.0%)
1,853 (1.4%)
Disability 906 (0.7%)
L 615 (0.4%)
H 265 (0.2%)
Life Threatening 265 (0.2%)
Death 102 (0.1%)
Congenital Anomaly 64 (0.0%)
D 15 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 54,377
Insufficient Device Problem Information 17,063
Patient-Device Incompatibility 5,657
Biocompatibility 5,472
Device Dislodged or Dislocated 5,303
Break 4,937
Migration 4,815
Migration or Expulsion of Device 3,400
Appropriate Device Problem Term/Code Not Available 2,292
Expulsion 2,252
Device Operates Differently Than Expected 1,068
Patient Device Interaction Problem 505
Malposition of Device 428
Difficult to Remove 371
Difficult to Insert 362
Mechanical Problem 279
Positioning Failure 207
Material Integrity Problem 198
Entrapment of Device 189
Material Fragmentation 171

Yearly Trend

94
1994: 1
98
1998: 1
02
2002: 1
03
2003: 3
04
2004: 7
05
2005: 17
06
2006: 25
07
2007: 25
08
2008: 56
09
2009: 133
10
2010: 126
11
2011: 113
12
2012: 153
13
2013: 800
14
2014: 2,236
15
2015: 5,954
16
2016: 4,929
17
2017: 11,847
18
2018: 5,983
19
2019: 15,085
20
2020: 16,135
21
2021: 3,725
22
2022: 1,640
23
2023: 3,637
24
2024: 848
25
2025: 756
26
2026: 266

Reports fell to 756 in 2025, down from an average of 2,243 in the two years before.

Related Entities for Transcervical Contraceptive Tubal Occlusion Device

Event Locations

I 58,958 (79.1%)
13,617 (18.3%)
NO INFORMATION 1,703 (2.3%)
HOSPITAL 198 (0.3%)
AMBULATORY SURGICAL FACILITY 12 (0.0%)
OTHER 6 (0.0%)
HOME 4 (0.0%)
UNKNOWN 2 (0.0%)
INVALID DATA 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare BAYER PHARMA AG vs BAYER →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Transcervical Contraceptive Tubal Occlusion…: 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 (74,502 here).

Similar death-typed counts

Nearest other device types by death-typed report count (137 here), distinct from the volume row.

Disclaimer: MAUDE figures for Transcervical Contraceptive Tubal Occlusion… 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 Transcervical Contraceptive Tubal Occlusion…; 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.