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2026 data FDA MAUDE openFDA

Dressing, Wound, Drug

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

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FDA MAUDE casebook

openFDA event book Dressing, Wound, Drug LIGHT-BOOK · MAUDE

#396 of 1000 · 3,144 reports · 1992–2026

  • BOOK 3,144 reports
  • RANK #396 of 1000
  • DEATH 63 death-typed
  • INJ 1,678 injury-typed
  • MALF 1,134 malfunction
  • SPAN 1992–2026
  • PEAK 2015: 297
  • PHOTO Culture Media

Nearest event-volume peer: Culture Media, Enriched (3 report gap)

Dressing, Wound, Drug sits #396 of 1000 among tracked device types with 3,144 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 sit below the device-type norm

Dressing, Wound, Drug carries 36.1% MALFUNCTION-coded reports, 28.8pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.0% corpus 1.5% · near corpus mean (+0.5 pp)
  • INJ 53.4% corpus 30.3% · above corpus mean (+23.1 pp)
  • MALF 36.1% corpus 64.8% · below corpus mean (-28.8 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 21% of coded problems · Lead manufacturer SMITH & NEPHEW MEDICAL LTD. accounts for 68% of manufacturer-tagged reports · Top event location is 60% of location-tagged rows .

Dressing, Wound, Drug in the event-volume neighbourhood

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

reports

What this shows Dressing, Wound, Drug carries 3,144 MAUDE reports, ranked #396 of 1000.

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

Event Types

Injury 1,678 (53.4%)
Malfunction 1,134 (36.1%)
Other 230 (7.3%)
Death 63 (2.0%)
39 (1.2%)

Patient Outcomes

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

1,366 (39.6%)
Other 794 (23.0%)
Required Intervention 601 (17.4%)
Hospitalization 210 (6.1%)
R 183 (5.3%)
Death 65 (1.9%)
O 62 (1.8%)
L 52 (1.5%)
Life Threatening 36 (1.0%)
H 32 (0.9%)
S 24 (0.7%)
Disability 21 (0.6%)
D 5 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 669
Delivered as Unsterile Product 451
Insufficient Device Problem Information 346
Unsealed Device Packaging 227
Contamination /Decontamination Problem 194
Patient-Device Incompatibility 176
Device Contamination with Chemical or Other Material 129
Unknown (for use when the device problem is not known) 123
Device Operates Differently Than Expected 117
Device Contaminated During Manufacture or Shipping 113
Contamination 110
Packaging Problem 85
Difficult to Remove 82
Improper or Incorrect Procedure or Method 78
Appropriate Device Problem Term/Code Not Available 66
Patient Device Interaction Problem 59
Use of Device Problem 53
Dislodged 45
Loose 35
Other (for use when an appropriate device code cannot be identified) 34

Yearly Trend

92
1992: 2
94
1994: 6
95
1995: 15
96
1996: 14
97
1997: 9
98
1998: 9
99
1999: 7
00
2000: 16
01
2001: 2
02
2002: 15
03
2003: 18
04
2004: 15
05
2005: 77
06
2006: 42
07
2007: 55
08
2008: 30
09
2009: 45
10
2010: 122
11
2011: 42
12
2012: 65
13
2013: 139
14
2014: 269
15
2015: 297
16
2016: 147
17
2017: 149
18
2018: 128
19
2019: 136
20
2020: 139
21
2021: 183
22
2022: 176
23
2023: 198
24
2024: 232
25
2025: 194
26
2026: 151

Reports in 2025 (194) held close to the prior two-year average of 215.

Related Entities for Dressing, Wound, Drug

Top Manufacturers

SMITH & NEPHEW MEDICAL LTD. 180
CONVATEC DOMINICAN REPUBLIC INC 86

Event Locations

1,873 (59.6%)
I 834 (26.5%)
HOSPITAL 181 (5.8%)
NO INFORMATION 141 (4.5%)
HOME 43 (1.4%)
UNKNOWN 25 (0.8%)
OTHER 18 (0.6%)
OUTPATIENT TREATMENT FACILITY 14 (0.4%)
INVALID DATA 6 (0.2%)
AMBULATORY SURGICAL FACILITY 3 (0.1%)
NOT APPLICABLE 3 (0.1%)
NURSING HOME 3 (0.1%)

Compare SMITH & NEPHEW MEDICAL LTD. vs CONVATEC DOMINICAN REPUBLIC INC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Dressing, Wound, Drug: 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 (3,144 here).

Culture Media, Enriched 3,141 Saline, Vascular Access Flush 3,148 Endoscopic Tissue Approximation Device 3,154 Dilator 3,156

Similar death-typed counts

Nearest other device types by death-typed report count (63 here), distinct from the volume row.

Colonoscope And Accessories, Flexible/Rigid 63 Electrode, Pacemaker, Temporary 65 Pancreatic Stent 65 Occluder, Patent Ductus, Arteriosus 60

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

Disclaimer: MAUDE figures for Dressing, Wound, Drug 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 Dressing, Wound, Drug; 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.