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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.

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

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

#391 of 1000 · 3,021 reports · 1992–2026

  • BOOK 3,021 reports
  • RANK #391 of 1000
  • DEATH 61 death-typed
  • INJ 1,604 injury-typed
  • MALF 1,088 malfunction
  • SPAN 1992–2026
  • PEAK 2015: 297
  • PHOTO Active Implantable Bo…

Nearest event-volume peer: Active Implantable Bone Conduction Hearing System (0 report gap)

Dressing, Wound, Drug sits #391 of 1000 among tracked device types with 3,021 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 →

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 2.0% corpus 1.5% · near corpus mean (+0.5 pp)
  • INJ 53.1% corpus 30.4% · above corpus mean (+22.7 pp)
  • MALF 36.0% corpus 64.5% · below corpus mean (-28.5 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 58% 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 3,021 MAUDE reports, ranked #391 of 1000.

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

Event Types

Injury 1,604 (53.1%)
Malfunction 1,088 (36.0%)
Other 229 (7.6%)
Death 61 (2.0%)
39 (1.3%)

Patient Outcomes

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

1,350 (40.0%)
Other 752 (22.3%)
Required Intervention 595 (17.7%)
Hospitalization 206 (6.1%)
R 180 (5.3%)
Death 63 (1.9%)
O 59 (1.8%)
L 52 (1.5%)
Life Threatening 35 (1.0%)
H 31 (0.9%)
S 23 (0.7%)
Disability 20 (0.6%)
D 5 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 432
Delivered as Unsterile Product 407
Unsealed Device Packaging 185
Contamination /Decontamination Problem 179
Insufficient Information 124
Device Contaminated During Manufacture or Shipping 110
Patient-Device Incompatibility 94
Contamination 93
Device Operates Differently Than Expected 65
Packaging Problem 63
Device Contamination with Chemical or Other Material 55
Appropriate Term/Code Not Available 52
Patient Device Interaction Problem 46
Difficult to Remove 31
Improper or Incorrect Procedure or Method 28
Device Damaged Prior to Use 27
Material Discolored 20
Use of Device Problem 19
No Apparent Adverse Event 14
Material Integrity Problem 13

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: 28

Related Entities for Dressing, Wound, Drug

Top Manufacturers

SMITH & NEPHEW MEDICAL LTD. 177
CONVATEC DOMINICAN REPUBLIC INC 84

Event Locations

1,746 (57.8%)
I 838 (27.7%)
HOSPITAL 181 (6.0%)
NO INFORMATION 141 (4.7%)
HOME 43 (1.4%)
UNKNOWN 25 (0.8%)
OTHER 18 (0.6%)
OUTPATIENT TREATMENT FACILITY 14 (0.5%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Dressing, Wound, Drug, 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 (3,021 here).

Active Implantable Bone Conduction Hearing… 3,021 Joint, Temporomandibular, Implant 3,015 Lenses, Soft Contact, Extended Wear 2,995 Prosthesis, Esophageal 3,051

Similar death-typed counts

Nearest other device types by death-typed report count (61 here), distinct from the volume row.

Drug-Eluting Percutaneous Transluminal Coro… 61 Tricuspid Valve Repair Device 61 Appliance 59 Colonoscope And Accessories, Flexible/Rigid 63

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.