PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Gown, Surgical

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 §878.4040 (General, Plastic Surgery panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Gown, Surgical LIGHT-BOOK · MAUDE

#741 of 1000 · 780 reports · 1994–2026

  • BOOK 780 reports
  • RANK #741 of 1000
  • DEATH 0 death-typed
  • INJ 80 injury-typed
  • MALF 634 malfunction
  • SPAN 1994–2026
  • PEAK 2018: 98
  • PHOTO Appliance

Nearest event-volume peer: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite (1 report gap)

Gown, Surgical sits #741 of 1000 among tracked device types with 780 MAUDE reports spanning 1994–2026. 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

Gown, Surgical carries 10.3% INJURY-coded reports, 20.0pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 10.3% corpus 30.3% · below corpus mean (-20.0 pp)
  • MALF 81.3% corpus 64.8% · above corpus mean (+16.5 pp)

Lead product-problem code Device Contamination with Chemical or Other Material is 24% of coded problems · Lead manufacturer STRYKER INSTRUMENTS-KALAMAZOO accounts for 79% of manufacturer-tagged reports · Top event location is 51% of location-tagged rows .

Gown, Surgical in the event-volume neighbourhood

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

reports

What this shows Gown, Surgical carries 780 MAUDE reports, ranked #741 of 1000.

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

Event Types

Malfunction 634 (81.3%)
Injury 80 (10.3%)
Other 57 (7.3%)
9 (1.2%)

Patient Outcomes

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

564 (71.8%)
Other 197 (25.1%)
Required Intervention 14 (1.8%)
R 7 (0.9%)
Life Threatening 2 (0.3%)
Disability 1 (0.1%)
Hospitalization 1 (0.1%)

Top Product Problems

Device Contamination with Chemical or Other Material 153
Material Integrity Problem 66
Torn Material 64
Material Split, Cut or Torn 58
Strikethrough 46
Material Separation 31
Fluid/Blood Leak 26
Hole In Material 24
Adverse Event Without Identified Device or Use Problem 20
Delivered as Unsterile Product 19
Appropriate Device Problem Term/Code Not Available 16
Insufficient Device Problem Information 15
Leak/Splash 15
Contamination 13
Protective Measures Problem 13
Device Contamination with Body Fluid 12
Material Puncture/Hole 10
Melted 10
Unknown (for use when the device problem is not known) 10
Unsealed Device Packaging 10

Yearly Trend

94
1994: 4
95
1995: 1
96
1996: 4
97
1997: 42
98
1998: 20
99
1999: 12
00
2000: 7
01
2001: 14
02
2002: 5
03
2003: 12
04
2004: 4
05
2005: 10
06
2006: 3
07
2007: 8
08
2008: 3
09
2009: 18
10
2010: 9
11
2011: 16
12
2012: 43
13
2013: 71
14
2014: 42
15
2015: 59
16
2016: 43
17
2017: 66
18
2018: 98
19
2019: 38
20
2020: 31
21
2021: 15
22
2022: 4
23
2023: 12
24
2024: 27
25
2025: 14
26
2026: 25

Reports in 2025 (14) held close to the prior two-year average of 20.

Related Entities for Gown, Surgical

Top Manufacturers

STRYKER INSTRUMENTS-KALAMAZOO 301
STRYKER INSTRUMENTS KALAMAZOO 39
CARDINAL HEALTH 21
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 18

Event Locations

394 (50.5%)
I 267 (34.2%)
HOSPITAL 89 (11.4%)
NO INFORMATION 20 (2.6%)
OTHER 5 (0.6%)
INVALID DATA 2 (0.3%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
NOT APPLICABLE 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare STRYKER INSTRUMENTS-KALAMAZOO vs STRYKER INSTRUMENTS KALAMAZOO →

Nationwide devices with a comparable report-volume footprint

Gown, Surgical carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (780 here).

Appliance 779 Computer 778 Support, Patient Position 782 Electrocautery, Gynecologic 777

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Gown, Surgical 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 Gown, Surgical; 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.