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2026 data FDA MAUDE openFDA FDA Class I

Restraint, Protective

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 §880.6760 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Restraint, Protective LIGHT-BOOK · MAUDE

#658 of 1000 · 1,027 reports · 1992–2026

  • BOOK 1,027 reports
  • RANK #658 of 1000
  • DEATH 221 death-typed
  • INJ 152 injury-typed
  • MALF 617 malfunction
  • SPAN 1992–2026
  • PEAK 2012: 71
  • PHOTO Stabilizer, Heart

Nearest event-volume peer: Stabilizer, Heart (2 report gap)

Restraint, Protective sits #658 of 1000 among tracked device types with 1,027 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 → · Similar-volume device →

Death-coded reports run above the device-type norm

Restraint, Protective carries 21.5% DEATH-coded reports, 20.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 21.5% corpus 1.5% · above corpus mean (+20.0 pp)
  • INJ 14.8% corpus 30.3% · below corpus mean (-15.5 pp)
  • MALF 60.1% corpus 64.8% · below corpus mean (-4.7 pp)

Lead product-problem code Break is 22% of coded problems · Top event location is 42% of location-tagged rows .

Restraint, Protective in the event-volume neighbourhood

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

reports

What this shows Restraint, Protective carries 1,027 MAUDE reports, ranked #658 of 1000.

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

Event Types

Malfunction 617 (60.1%)
Death 221 (21.5%)
Injury 152 (14.8%)
Other 23 (2.2%)
14 (1.4%)

Patient Outcomes

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

612 (57.4%)
Death 200 (18.7%)
Other 101 (9.5%)
Required Intervention 63 (5.9%)
Hospitalization 23 (2.2%)
Life Threatening 20 (1.9%)
R 15 (1.4%)
L 10 (0.9%)
O 9 (0.8%)
Disability 8 (0.7%)
S 3 (0.3%)
H 2 (0.2%)
Invalid Data 1 (0.1%)

Top Product Problems

Break 167
Unknown (for use when the device problem is not known) 107
Other (for use when an appropriate device code cannot be identified) 62
Device Slipped 60
Adverse Event Without Identified Device or Use Problem 52
Use of Device Problem 35
Mechanical Problem 30
Insufficient Device Problem Information 27
Tears, rips, holes in device, device material 26
Device Operates Differently Than Expected 21
Locking mechanism failure 21
Improper or Incorrect Procedure or Method 20
Torn Material 19
Detachment Of Device Component 18
Mechanics Altered 18
Material Separation 17
Material Split, Cut or Torn 15
Appropriate Device Problem Term/Code Not Available 14
Difficult to Open or Close 14
Loose 14

Yearly Trend

92
1992: 7
93
1993: 14
94
1994: 25
95
1995: 26
96
1996: 44
97
1997: 45
98
1998: 27
99
1999: 33
00
2000: 17
01
2001: 18
02
2002: 14
03
2003: 13
04
2004: 7
05
2005: 15
06
2006: 9
07
2007: 16
08
2008: 10
09
2009: 42
10
2010: 20
11
2011: 31
12
2012: 71
13
2013: 31
14
2014: 43
15
2015: 33
16
2016: 24
17
2017: 54
18
2018: 23
19
2019: 57
20
2020: 38
21
2021: 33
22
2022: 54
23
2023: 47
24
2024: 58
25
2025: 15
26
2026: 13

Reports fell to 15 in 2025, down from an average of 53 in the two years before.

Related Entities for Restraint, Protective

Event Locations

434 (42.3%)
HOSPITAL 259 (25.2%)
I 208 (20.3%)
NURSING HOME 79 (7.7%)
INVALID DATA 23 (2.2%)
NO INFORMATION 8 (0.8%)
OTHER 7 (0.7%)
HOME 6 (0.6%)
NOT APPLICABLE 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Restraint, Protective: 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 (1,027 here).

Stabilizer, Heart 1,025 Motor 1,030 Bath, Hydro-Massage 1,022 Blood Establishment Computer Software And A… 1,034

Similar death-typed counts

Nearest other device types by death-typed report count (221 here), distinct from the volume row.

Shunt, Central Nervous System And Components 222 System, X-Ray, Tomography, Computed 219 Catheter 218 Pump, Infusion, Pca 225

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

Disclaimer: MAUDE figures for Restraint, Protective 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 Restraint, Protective; 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.