2026 data FDA MAUDE openFDA FDA Class I

Adaptor, Hygiene

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §890.5050 (Physical Medicine panel).

FDA MAUDE casebook

openFDA event book Adaptor, Hygiene LIGHT-BOOK · MAUDE

#378 of 1000 · 3,426 reports · 1995–2026

  • BOOK 3,426 reports
  • RANK #378 of 1000
  • DEATH 10 death-typed
  • INJ 417 injury-typed
  • MALF 2,617 malfunction
  • SPAN 1995–2026
  • PEAK 2014: 705
  • PHOTO Active Implantable Bo…

Nearest event-volume peer: Active Implantable Bone Conduction Hearing System (11 report gap)

Adaptor, Hygiene sits #378 of 1000 among tracked device types with 3,426 MAUDE reports spanning 1995–2026. 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 sit below the device-type norm

Adaptor, Hygiene carries 12.2% INJURY-coded reports, 18.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 12.2% corpus 30.3% · below corpus mean (-18.1 pp)
  • MALF 76.4% corpus 64.8% · above corpus mean (+11.6 pp)

Lead product-problem code Crack is 34% of coded problems · Lead manufacturer INVAMEX accounts for 43% of manufacturer-tagged reports · Top event location is 70% of location-tagged rows .

Adaptor, Hygiene in the event-volume neighbourhood

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

reports

What this shows Adaptor, Hygiene carries 3,426 MAUDE reports, ranked #378 of 1000.

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

Event Types

Malfunction 2,617 (76.4%)
Injury 417 (12.2%)
374 (10.9%)
Death 10 (0.3%)
Other 7 (0.2%)
No answer provided 1 (0.0%)

Patient Outcomes

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

Other 2,073 (66.0%)
819 (26.1%)
Required Intervention 105 (3.3%)
Hospitalization 69 (2.2%)
R 38 (1.2%)
Death 10 (0.3%)
O 8 (0.3%)
S 8 (0.3%)
H 6 (0.2%)
Life Threatening 3 (0.1%)
L 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Crack 1,139
Break 638
Bent 255
Unstable 214
Material Twisted/Bent 200
Fracture 113
Loose or Intermittent Connection 106
Collapse 101
Product Quality Problem 72
Device Operates Differently Than Expected 70
Out-Of-Box Failure 68
Detachment Of Device Component 66
Material Integrity Problem 62
Component Missing 51
Adverse Event Without Identified Device or Use Problem 46
Device Slipped 39
Insufficient Device Problem Information 39
Mechanical Problem 39
Detachment of Device or Device Component 38
Split 31

Yearly Trend

95
1995: 1
03
2003: 2
04
2004: 1
05
2005: 3
06
2006: 1
09
2009: 1
10
2010: 6
11
2011: 21
12
2012: 114
13
2013: 553
14
2014: 705
15
2015: 702
16
2016: 411
17
2017: 48
18
2018: 36
19
2019: 50
20
2020: 32
21
2021: 27
22
2022: 45
23
2023: 59
24
2024: 37
25
2025: 47
26
2026: 524

Reports in 2025 (47) held close to the prior two-year average of 48.

Related Entities for Adaptor, Hygiene

Top Manufacturers

Event Locations

2,414 (70.5%)
I 641 (18.7%)
HOME 217 (6.3%)
NO INFORMATION 72 (2.1%)
HOSPITAL 33 (1.0%)
OTHER 33 (1.0%)
NURSING HOME 14 (0.4%)
INVALID DATA 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare INVAMEX vs UNKNOWN →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Adaptor, Hygiene: 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 (3,426 here).

Similar death-typed counts

Nearest other device types by death-typed report count (10 here), distinct from the volume row.

Disclaimer: MAUDE figures for Adaptor, Hygiene 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 Adaptor, Hygiene; 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.