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2026 data FDA MAUDE openFDA FDA Class II

Drape, Surgical, Antimicrobial

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 §878.4370 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Drape, Surgical, Antimicrobial LIGHT-BOOK · MAUDE

#731 of 1000 · 803 reports · 1993–2026

  • BOOK 803 reports
  • RANK #731 of 1000
  • DEATH 10 death-typed
  • INJ 198 injury-typed
  • MALF 453 malfunction
  • SPAN 1993–2026
  • PEAK 2013: 63
  • PHOTO System

Nearest event-volume peer: System, Planning, Radiation Therapy Treatment (1 report gap)

Drape, Surgical, Antimicrobial sits #731 of 1000 among tracked device types with 803 MAUDE reports spanning 1993–2026. 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 sit below the device-type norm

Drape, Surgical, Antimicrobial carries 56.4% MALFUNCTION-coded reports, 8.4pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.2% corpus 1.5% · near corpus mean (-0.3 pp)
  • INJ 24.7% corpus 30.3% · below corpus mean (-5.6 pp)
  • MALF 56.4% corpus 64.8% · below corpus mean (-8.4 pp)

Lead product-problem code Hole In Material is 12% of coded problems · Lead manufacturer CARDINAL HEALTH accounts for 100% of manufacturer-tagged reports · Top event location is 41% of location-tagged rows .

Drape, Surgical, Antimicrobial in the event-volume neighbourhood

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

reports

What this shows Drape, Surgical, Antimicrobial carries 803 MAUDE reports, ranked #731 of 1000.

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

Event Types

Malfunction 453 (56.4%)
Injury 198 (24.7%)
Other 99 (12.3%)
43 (5.4%)
Death 10 (1.2%)

Patient Outcomes

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

434 (51.0%)
Other 239 (28.1%)
Required Intervention 94 (11.0%)
R 31 (3.6%)
Hospitalization 21 (2.5%)
Death 9 (1.1%)
O 6 (0.7%)
S 5 (0.6%)
Life Threatening 4 (0.5%)
H 3 (0.4%)
L 3 (0.4%)
Disability 2 (0.2%)

Top Product Problems

Hole In Material 66
Unknown (for use when the device problem is not known) 46
Fluid/Blood Leak 40
Adverse Event Without Identified Device or Use Problem 39
Difficult to Remove 36
Leak/Splash 33
Material Puncture/Hole 32
Insufficient Device Problem Information 30
Break 26
Device Contamination with Chemical or Other Material 25
Unsealed Device Packaging 25
Contamination 24
Device Operates Differently Than Expected 24
Device Contamination with Body Fluid 21
Torn Material 17
Appropriate Device Problem Term/Code Not Available 16
Material Separation 16
Material Split, Cut or Torn 16
Contamination /Decontamination Problem 15
Detachment Of Device Component 15

Yearly Trend

93
1993: 1
94
1994: 1
95
1995: 5
96
1996: 11
97
1997: 31
98
1998: 9
99
1999: 11
00
2000: 10
01
2001: 9
02
2002: 11
03
2003: 23
04
2004: 11
05
2005: 12
06
2006: 18
07
2007: 24
08
2008: 24
09
2009: 27
10
2010: 25
11
2011: 57
12
2012: 40
13
2013: 63
14
2014: 28
15
2015: 33
16
2016: 56
17
2017: 30
18
2018: 32
19
2019: 41
20
2020: 16
21
2021: 41
22
2022: 19
23
2023: 32
24
2024: 19
25
2025: 24
26
2026: 9

Reports in 2025 (24) held close to the prior two-year average of 26.

Related Entities for Drape, Surgical, Antimicrobial

Top Manufacturers

CARDINAL HEALTH 42

Event Locations

333 (41.5%)
HOSPITAL 301 (37.5%)
I 110 (13.7%)
NO INFORMATION 33 (4.1%)
INVALID DATA 12 (1.5%)
AMBULATORY SURGICAL FACILITY 5 (0.6%)
OTHER 4 (0.5%)
UNKNOWN 2 (0.2%)
HOME 1 (0.1%)
NURSING HOME 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Drape, Surgical, Antimicrobial: 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 (803 here).

System 804 Humidifier, Non-Direct Patient Interface 801 Heparin, Vascular Access Flush 800 Intracranial Coil-Assist Stent 806

Similar death-typed counts

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

Accessories, Catheter 10 Adaptor, Hygiene 10 Blood Pump For Ecmo, Long-Term Use 10 Chair, Adjustable, Mechanical 10

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

Disclaimer: MAUDE figures for Drape, Surgical, Antimicrobial 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 Drape, Surgical, Antimicrobial; 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.