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2026 data FDA MAUDE openFDA FDA Class II

Condom

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 §884.5300 (Obstetrics/Gynecology panel).

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FDA MAUDE casebook

openFDA event book Condom LIGHT-BOOK · MAUDE

#963 of 1000 · 408 reports · 1993–2026

  • BOOK 408 reports
  • RANK #963 of 1000
  • DEATH 3 death-typed
  • INJ 157 injury-typed
  • MALF 92 malfunction
  • SPAN 1993–2026
  • PEAK 2010: 22
  • PHOTO Enzyme Immunoassay

Nearest event-volume peer: Enzyme Immunoassay, Phenobarbital (1 report gap)

Condom sits #963 of 1000 among tracked device types with 408 MAUDE reports spanning 1993–2026. 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 sit below the device-type norm

Condom carries 22.5% MALFUNCTION-coded reports, 42.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 38.5% corpus 30.3% · above corpus mean (+8.2 pp)
  • MALF 22.5% corpus 64.8% · below corpus mean (-42.3 pp)

Lead product-problem code Break is 32% of coded problems · Lead manufacturer UNK accounts for 100% of manufacturer-tagged reports · Top event location is 52% of location-tagged rows .

Condom in the event-volume neighbourhood

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

reports

What this shows Condom carries 408 MAUDE reports, ranked #963 of 1000.

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

Event Types

Injury 157 (38.5%)
Other 137 (33.6%)
Malfunction 92 (22.5%)
19 (4.7%)
Death 3 (0.7%)

Patient Outcomes

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

Other 229 (51.0%)
108 (24.1%)
Required Intervention 32 (7.1%)
Hospitalization 19 (4.2%)
O 14 (3.1%)
R 10 (2.2%)
Disability 9 (2.0%)
S 7 (1.6%)
Life Threatening 7 (1.6%)
H 6 (1.3%)
L 4 (0.9%)
Death 3 (0.7%)
Congenital Anomaly 1 (0.2%)

Top Product Problems

Break 114
Insufficient Device Problem Information 42
Reaction 36
Unknown (for use when the device problem is not known) 26
Adverse Event Without Identified Device or Use Problem 20
Patient-Device Incompatibility 20
Tears, rips, holes in device, device material 13
Design/structure problem 12
Material Rupture 12
Device Slipped 7
Defective Device 6
Device Operates Differently Than Expected 6
Therapeutic or Diagnostic Output Failure 6
Device Contamination with Chemical or Other Material 5
Entrapment of Device 5
Material Fragmentation 5
Product Quality Problem 5
Detachment Of Device Component 4
Device, removal of (non-implant) 4
Other (for use when an appropriate device code cannot be identified) 4

Yearly Trend

93
1993: 1
94
1994: 13
95
1995: 3
96
1996: 15
97
1997: 21
98
1998: 14
99
1999: 13
00
2000: 7
01
2001: 12
02
2002: 15
03
2003: 9
04
2004: 10
05
2005: 12
06
2006: 10
07
2007: 10
08
2008: 11
09
2009: 12
10
2010: 22
11
2011: 15
12
2012: 10
13
2013: 19
14
2014: 16
15
2015: 8
16
2016: 5
17
2017: 8
18
2018: 11
19
2019: 15
20
2020: 12
21
2021: 16
22
2022: 18
23
2023: 10
24
2024: 7
25
2025: 21
26
2026: 7

Reports rose to 21 in 2025, up from an average of 9 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Condom

Top Manufacturers

UNK 14

Event Locations

211 (51.7%)
HOME 53 (13.0%)
OTHER 40 (9.8%)
I 39 (9.6%)
UNKNOWN 22 (5.4%)
INVALID DATA 15 (3.7%)
NO INFORMATION 14 (3.4%)
NOT APPLICABLE 8 (2.0%)
HOSPITAL 3 (0.7%)
OUTPATIENT TREATMENT FACILITY 2 (0.5%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Condom: 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 (408 here).

Enzyme Immunoassay, Phenobarbital 409 Processor 410 Manometer, Spinal-Fluid 411 Mass Spectrometry 411

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

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

Disclaimer: MAUDE figures for Condom 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 Condom; 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.