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2026 data FDA MAUDE openFDA

Dressing, Wound, Occlusive

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, Occlusive MID-BOOK · MAUDE

#170 of 1000 · 14,583 reports · 2004–2026

  • BOOK 14,583 reports
  • RANK #170 of 1000
  • DEATH 7 death-typed
  • INJ 883 injury-typed
  • MALF 13,671 malfunction
  • SPAN 2004–2026
  • PEAK 2020: 5,035
  • PHOTO Laparoscope

Nearest event-volume peer: Laparoscope, Gynecologic (And Accessories) (2 report gap)

Dressing, Wound, Occlusive sits #170 of 1000 among tracked device types with 14,583 MAUDE reports spanning 2004–2026. 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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 6.1% corpus 30.4% · below corpus mean (-24.4 pp)
  • MALF 93.7% corpus 64.5% · above corpus mean (+29.2 pp)

Lead product-problem code Delivered as Unsterile Product is 33% of coded problems · Lead manufacturer CONVATEC DOMINICAN REPUBLIC INC accounts for 94% of manufacturer-tagged reports · Top event location is 51% of location-tagged rows .

Dressing, Wound, Occlusive in the event-volume neighbourhood

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

reports

What this shows Dressing, Wound, Occlusive carries 14,583 MAUDE reports, ranked #170 of 1000.

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

Event Types

Malfunction 13,671 (93.7%)
Injury 883 (6.1%)
Other 21 (0.1%)
Death 7 (0.0%)
1 (0.0%)

Patient Outcomes

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

13,724 (93.5%)
Required Intervention 457 (3.1%)
Other 287 (2.0%)
R 85 (0.6%)
Hospitalization 70 (0.5%)
H 11 (0.1%)
O 10 (0.1%)
Disability 9 (0.1%)
S 8 (0.1%)
Death 6 (0.0%)
L 3 (0.0%)
Life Threatening 2 (0.0%)

Top Product Problems

Delivered as Unsterile Product 7,487
Contamination /Decontamination Problem 6,053
Device Contamination with Chemical or Other Material 5,718
Unsealed Device Packaging 647
Packaging Problem 509
Adverse Event Without Identified Device or Use Problem 464
Difficult to Remove 382
Device Damaged Prior to Use 265
Device Contaminated During Manufacture or Shipping 167
Loss of or Failure to Bond 162
Material Disintegration 132
Nonstandard Device 119
Insufficient Information 72
Material Integrity Problem 64
Use of Device Problem 52
Appropriate Term/Code Not Available 51
Tear, Rip or Hole in Device Packaging 45
Failure To Adhere Or Bond 38
Material Separation 27
Device Operates Differently Than Expected 26

Yearly Trend

04
2004: 9
05
2005: 6
06
2006: 8
07
2007: 1
08
2008: 8
09
2009: 9
10
2010: 30
11
2011: 9
12
2012: 3
13
2013: 15
14
2014: 63
15
2015: 251
16
2016: 106
17
2017: 134
18
2018: 1,029
19
2019: 588
20
2020: 5,035
21
2021: 451
22
2022: 403
23
2023: 1,619
24
2024: 1,804
25
2025: 2,667
26
2026: 335

Related Entities for Dressing, Wound, Occlusive

Top Manufacturers

CONVATEC DOMINICAN REPUBLIC INC 12,506
SMITH & NEPHEW MEDICAL LTD. 734

Event Locations

7,507 (51.5%)
I 6,825 (46.8%)
OTHER 206 (1.4%)
NO INFORMATION 26 (0.2%)
HOSPITAL 12 (0.1%)
HOME 4 (0.0%)
UNKNOWN 2 (0.0%)
INVALID DATA 1 (0.0%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Dressing, Wound, Occlusive, 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 (14,583 here).

Laparoscope, Gynecologic 14,581 Tube Tracheostomy And Tube Cuff 14,497 Pump, Infusion, Enteral 14,791 Suture, Surgical, Absorbable, Polydioxanone 14,884

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Device, Warming. Blood And Plasma 7 Image-Intensified Fluoroscopic X-Ray System 7 Instrument 7 Intrauterine Tamponade Balloon 7

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

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