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2026 data FDA MAUDE openFDA FDA Class I

Tourniquet, Pneumatic

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 §878.5910 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Tourniquet, Pneumatic LIGHT-BOOK · MAUDE

#504 of 1000 · 1,989 reports · 1992–2026

  • BOOK 1,989 reports
  • RANK #504 of 1000
  • DEATH 1 death-typed
  • INJ 231 injury-typed
  • MALF 1,726 malfunction
  • SPAN 1992–2026
  • PEAK 2023: 347
  • PHOTO Trocar

Nearest event-volume peer: Trocar (5 report gap)

Tourniquet, Pneumatic sits #504 of 1000 among tracked device types with 1,989 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 →

Malfunction reports run above the device-type norm

Tourniquet, Pneumatic carries 86.8% MALFUNCTION-coded reports, 21.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 11.6% corpus 30.3% · below corpus mean (-18.7 pp)
  • MALF 86.8% corpus 64.8% · above corpus mean (+21.9 pp)

Lead product-problem code Leak/Splash is 19% of coded problems · Lead manufacturer ZIMMER SURGICAL, INC. accounts for 56% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Tourniquet, Pneumatic in the event-volume neighbourhood

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

reports

What this shows Tourniquet, Pneumatic carries 1,989 MAUDE reports, ranked #504 of 1000.

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

Event Types

Malfunction 1,726 (86.8%)
Injury 231 (11.6%)
Other 20 (1.0%)
11 (0.6%)
Death 1 (0.1%)

Patient Outcomes

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

1,711 (84.6%)
Other 150 (7.4%)
Required Intervention 92 (4.5%)
R 19 (0.9%)
Disability 11 (0.5%)
Life Threatening 11 (0.5%)
S 10 (0.5%)
Hospitalization 10 (0.5%)
O 6 (0.3%)
Death 1 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Leak/Splash 350
Decrease in Pressure 309
Gas/Air Leak 226
Pressure Problem 223
Air Leak 121
Inflation Problem 116
Deflation Problem 89
Device Operates Differently Than Expected 85
Delivered as Unsterile Product 49
Increase in Pressure 44
Measurement System Incompatibility 44
Device Alarm System 38
Device Displays Incorrect Message 28
Unknown (for use when the device problem is not known) 27
Insufficient Device Problem Information 26
Break 24
Deflation, cause unknown 20
Replace 20
Fluid/Blood Leak 17
Material Split, Cut or Torn 17

Yearly Trend

92
1992: 2
93
1993: 3
94
1994: 4
95
1995: 6
96
1996: 9
97
1997: 14
98
1998: 29
99
1999: 9
00
2000: 23
01
2001: 22
02
2002: 14
03
2003: 8
04
2004: 9
05
2005: 11
06
2006: 9
07
2007: 19
08
2008: 33
09
2009: 46
10
2010: 47
11
2011: 61
12
2012: 67
13
2013: 55
14
2014: 63
15
2015: 43
16
2016: 72
17
2017: 110
18
2018: 145
19
2019: 129
20
2020: 119
21
2021: 130
22
2022: 90
23
2023: 347
24
2024: 107
25
2025: 121
26
2026: 13

Reports fell to 121 in 2025, down from an average of 227 in the two years before.

Related Entities for Tourniquet, Pneumatic

Top Manufacturers

ZIMMER SURGICAL, INC. 567
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 206
STRYKER INSTRUMENTS-KALAMAZOO 183
STRYKER INSTRUMENTS KALAMAZOO 56

Event Locations

1,080 (54.3%)
I 629 (31.6%)
HOSPITAL 224 (11.3%)
NO INFORMATION 31 (1.6%)
AMBULATORY SURGICAL FACILITY 8 (0.4%)
INVALID DATA 7 (0.4%)
OTHER 3 (0.2%)
OPERATING ROOM 2 (0.1%)
OUTPATIENT TREATMENT FACILITY 2 (0.1%)
UNKNOWN 2 (0.1%)
HOME 1 (0.1%)

Compare ZIMMER SURGICAL, INC. vs STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Tourniquet, Pneumatic: 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 (1,989 here).

Trocar 1,994 Monitor, Physiological, Patient 1,983 Radioimmunoassay, Total Triiodothyronine 1,979 Electrode, Pacemaker, Temporary 2,012

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Tourniquet, Pneumatic 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 Tourniquet, Pneumatic; 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.