2026 data FDA MAUDE openFDA FDA Class I

Wheelchair, Mechanical

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 §890.3850 (Physical Medicine panel).

FDA MAUDE casebook

openFDA event book Wheelchair, Mechanical MID-BOOK · MAUDE

#116 of 1000 · 26,370 reports · 1992–2026

  • BOOK 26,370 reports
  • RANK #116 of 1000
  • DEATH 55 death-typed
  • INJ 1,060 injury-typed
  • MALF 23,320 malfunction
  • SPAN 1992–2026
  • PEAK 2014: 5,082
  • PHOTO Device

Nearest event-volume peer: Device, Neurovascular Embolization (159 report gap)

Wheelchair, Mechanical sits #116 of 1000 among tracked device types with 26,370 MAUDE reports spanning 1992–2026. 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

Wheelchair, Mechanical carries 4.0% INJURY-coded reports, 26.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 4.0% corpus 30.3% · below corpus mean (-26.3 pp)
  • MALF 88.4% corpus 64.8% · above corpus mean (+23.6 pp)

Lead product-problem code Break is 37% of coded problems · Lead manufacturer INVAMEX accounts for 57% of manufacturer-tagged reports · Top event location is 77% of location-tagged rows .

Wheelchair, Mechanical in the event-volume neighbourhood

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

reports

What this shows Wheelchair, Mechanical carries 26,370 MAUDE reports, ranked #116 of 1000.

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

Event Types

Malfunction 23,320 (88.4%)
1,795 (6.8%)
Injury 1,060 (4.0%)
Other 140 (0.5%)
Death 55 (0.2%)

Patient Outcomes

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

Other 21,302 (81.5%)
3,695 (14.1%)
Required Intervention 495 (1.9%)
Hospitalization 313 (1.2%)
R 133 (0.5%)
Death 62 (0.2%)
O 47 (0.2%)
Disability 24 (0.1%)
S 23 (0.1%)
H 16 (0.1%)
Life Threatening 12 (0.0%)
Congenital Anomaly 9 (0.0%)
L 4 (0.0%)

Top Product Problems

Break 8,457
Component(s), broken 2,516
Bent 1,899
Device Operates Differently Than Expected 1,355
Detachment Of Device Component 1,304
Crack 1,135
Mechanical Problem 1,021
Device Slipped 841
Fracture 602
Unstable 532
Torn Material 440
Naturally Worn 433
Detachment of Device or Device Component 384
Component Falling 372
Component Missing 337
Product Quality Problem 316
Loose or Intermittent Connection 305
Material Integrity Problem 295
Out-Of-Box Failure 285
Material Separation 275

Yearly Trend

92
1992: 20
93
1993: 9
94
1994: 19
95
1995: 12
96
1996: 749
97
1997: 1,798
98
1998: 1,571
99
1999: 1,178
00
2000: 1,071
01
2001: 329
02
2002: 212
03
2003: 38
04
2004: 55
05
2005: 37
06
2006: 38
07
2007: 36
08
2008: 62
09
2009: 54
10
2010: 69
11
2011: 232
12
2012: 1,238
13
2013: 4,674
14
2014: 5,082
15
2015: 4,472
16
2016: 1,860
17
2017: 49
18
2018: 58
19
2019: 53
20
2020: 43
21
2021: 59
22
2022: 37
23
2023: 165
24
2024: 138
25
2025: 138
26
2026: 715

Reports in 2025 (138) held close to the prior two-year average of 152.

Related Entities for Wheelchair, Mechanical

Top Manufacturers

Event Locations

20,357 (77.2%)
I 3,428 (13.0%)
INVALID DATA 1,289 (4.9%)
UNKNOWN 487 (1.8%)
OTHER 226 (0.9%)
NO INFORMATION 179 (0.7%)
HOSPITAL 137 (0.5%)
NURSING HOME 129 (0.5%)
HOME 122 (0.5%)
NOT APPLICABLE 7 (0.0%)
OUTPATIENT TREATMENT FACILITY 4 (0.0%)
PUBLIC VENUE 3 (0.0%)
REHABILITATION CENTER 1 (0.0%)
STREET 1 (0.0%)

Compare INVAMEX vs INVACARE TAYLOR STREET →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Wheelchair, Mechanical: 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 (26,370 here).

Similar death-typed counts

Nearest other device types by death-typed report count (55 here), distinct from the volume row.

Disclaimer: MAUDE figures for Wheelchair, Mechanical 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 Wheelchair, Mechanical; 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.