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2026 data FDA MAUDE openFDA

Drape, 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.

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FDA MAUDE casebook

openFDA event book Drape, Surgical LIGHT-BOOK · MAUDE

#717 of 1000 · 797 reports · 1993–2026

  • BOOK 797 reports
  • RANK #717 of 1000
  • DEATH 10 death-typed
  • INJ 198 injury-typed
  • MALF 447 malfunction
  • SPAN 1993–2026
  • PEAK 2013: 63
  • PHOTO Humidifier

Nearest event-volume peer: Humidifier, Non-Direct Patient Interface (Home-Use) (0 report gap)

Drape, Surgical sits #717 of 1000 among tracked device types with 797 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 1.3% corpus 1.5% · near corpus mean (-0.3 pp)
  • INJ 24.8% corpus 30.4% · below corpus mean (-5.6 pp)
  • MALF 56.1% corpus 64.5% · below corpus mean (-8.4 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 13% 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 in the event-volume neighbourhood

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

reports

What this shows Drape, Surgical carries 797 MAUDE reports, ranked #717 of 1000.

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

Event Types

Malfunction 447 (56.1%)
Injury 198 (24.8%)
Other 99 (12.4%)
43 (5.4%)
Death 10 (1.3%)

Patient Outcomes

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

431 (51.0%)
Other 236 (27.9%)
Required Intervention 94 (11.1%)
R 31 (3.7%)
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

Adverse Event Without Identified Device or Use Problem 33
Material Puncture/Hole 31
Hole In Material 25
Leak/Splash 20
Device Contamination with Body Fluid 17
Material Split, Cut or Torn 16
Break 13
Device Contamination with Chemical or Other Material 12
Contamination /Decontamination Problem 11
Human-Device Interface Problem 11
Contamination 10
Appropriate Term/Code Not Available 9
Manufacturing, Packaging or Shipping Problem 8
Insufficient Information 7
Detachment of Device or Device Component 6
Fluid/Blood Leak 6
Torn Material 6
Delivered as Unsterile Product 4
Detachment Of Device Component 4
Device Contaminated During Manufacture or Shipping 4

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: 3

Related Entities for Drape, Surgical

Top Manufacturers

CARDINAL HEALTH 42

Event Locations

330 (41.4%)
HOSPITAL 298 (37.4%)
I 110 (13.8%)
NO INFORMATION 33 (4.1%)
INVALID DATA 12 (1.5%)
AMBULATORY SURGICAL FACILITY 5 (0.6%)
OTHER 4 (0.5%)
UNKNOWN 2 (0.3%)
HOME 1 (0.1%)
NURSING HOME 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Drape, Surgical, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (797 here).

Humidifier, Non-Direct Patient Interface 797 System 797 Heparin, Vascular Access Flush 799 Intrasaccular Flow Disruption Device 794

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 Cabinet, Table And Tray, Anesthesia 10 Chair, Adjustable, Mechanical 10

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

Disclaimer: MAUDE figures for Drape, 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 Drape, 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.