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2026 data FDA MAUDE openFDA FDA Class I

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.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4020 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Dressing, Wound, Occlusive MID-BOOK · MAUDE

#171 of 1000 · 15,775 reports · 2004–2026

  • BOOK 15,775 reports
  • RANK #171 of 1000
  • DEATH 7 death-typed
  • INJ 902 injury-typed
  • MALF 14,844 malfunction
  • SPAN 2004–2026
  • PEAK 2020: 5,035
  • PHOTO Suture

Nearest event-volume peer: Suture, Surgical, Absorbable, Polydioxanone (91 report gap)

Dressing, Wound, Occlusive sits #171 of 1000 among tracked device types with 15,775 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 →

Malfunction reports run above the device-type norm

Dressing, Wound, Occlusive carries 94.1% MALFUNCTION-coded reports, 29.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 5.7% corpus 30.3% · below corpus mean (-24.6 pp)
  • MALF 94.1% corpus 64.8% · above corpus mean (+29.3 pp)

Lead product-problem code Delivered as Unsterile Product is 34% of coded problems · Lead manufacturer CONVATEC DOMINICAN REPUBLIC INC accounts for 91% of manufacturer-tagged reports · Top event location is 55% 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 15,775 MAUDE reports, ranked #171 of 1000.

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

Event Types

Malfunction 14,844 (94.1%)
Injury 902 (5.7%)
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.

14,797 (93.9%)
Required Intervention 461 (2.9%)
Other 300 (1.9%)
R 85 (0.5%)
Hospitalization 70 (0.4%)
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 3 (0.0%)

Top Product Problems

Delivered as Unsterile Product 8,460
Contamination /Decontamination Problem 6,939
Device Contamination with Chemical or Other Material 5,776
Unsealed Device Packaging 725
Adverse Event Without Identified Device or Use Problem 557
Packaging Problem 521
Difficult to Remove 401
Device Damaged Prior to Use 363
Loss of or Failure to Bond 168
Device Contaminated During Manufacture or Shipping 166
Material Disintegration 133
Nonstandard Device 125
Insufficient Device Problem Information 124
Tear, Rip or Hole in Device Packaging 107
Failure To Adhere Or Bond 85
Material Integrity Problem 74
Use of Device Problem 55
Device Operates Differently Than Expected 53
Appropriate Device Problem Term/Code Not Available 51
Device Damaged Prior to Receipt by User 37

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: 1,028
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: 1,528

Reports rose to 2,667 in 2025, up from an average of 1,712 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Dressing, Wound, Occlusive

Top Manufacturers

CONVATEC DOMINICAN REPUBLIC INC 13,068
SMITH & NEPHEW MEDICAL LTD. 737
ConvaTec Dominican Republic Inc 606

Event Locations

8,697 (55.1%)
I 6,824 (43.3%)
OTHER 209 (1.3%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Dressing, Wound, Occlusive: 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 (15,775 here).

Suture, Surgical, Absorbable, Polydioxanone 15,866 Catheter, Urological And Accessories 16,326 Endoscopic Ultrasound System 16,331 Prosthesis 16,332

Similar death-typed counts

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

Device, Percutaneous Retrieval 7 Instrument 7 Joint, Temporomandibular, Implant 7 Mesh, Surgical, Absorbable, Abdominal Hernia 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.