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2026 data FDA MAUDE openFDA

Dressing, Wound, Hydrophilic

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, Hydrophilic LIGHT-BOOK · MAUDE

#594 of 1000 · 1,269 reports · 2005–2026

  • BOOK 1,269 reports
  • RANK #594 of 1000
  • DEATH 6 death-typed
  • INJ 299 injury-typed
  • MALF 958 malfunction
  • SPAN 2005–2026
  • PEAK 2015: 243
  • PHOTO Bone Mill

Nearest event-volume peer: Bone Mill (0 report gap)

Dressing, Wound, Hydrophilic sits #594 of 1000 among tracked device types with 1,269 MAUDE reports spanning 2005–2026. 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 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 23.6% corpus 30.4% · below corpus mean (-6.9 pp)
  • MALF 75.5% corpus 64.5% · above corpus mean (+11.0 pp)

Lead product-problem code Delivered as Unsterile Product is 36% of coded problems · Lead manufacturer CONVATEC DOMINICAN REPUBLIC INC accounts for 58% of manufacturer-tagged reports · Top event location I is 56% of location-tagged rows .

Dressing, Wound, Hydrophilic in the event-volume neighbourhood

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

reports

What this shows Dressing, Wound, Hydrophilic carries 1,269 MAUDE reports, ranked #594 of 1000.

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

Event Types

Malfunction 958 (75.5%)
Injury 299 (23.6%)
Death 6 (0.5%)
4 (0.3%)
Other 2 (0.2%)

Patient Outcomes

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

991 (77.4%)
Required Intervention 185 (14.4%)
Other 59 (4.6%)
Hospitalization 20 (1.6%)
R 13 (1.0%)
Death 6 (0.5%)
O 2 (0.2%)
H 1 (0.1%)
L 1 (0.1%)
S 1 (0.1%)
Disability 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Delivered as Unsterile Product 534
Device Contamination with Chemical or Other Material 222
Unsealed Device Packaging 174
Contamination /Decontamination Problem 143
Difficult to Remove 86
Adverse Event Without Identified Device or Use Problem 83
Packaging Problem 52
Patient-Device Incompatibility 33
Nonstandard Device 26
Material Disintegration 25
Device Damaged Prior to Use 24
Material Fragmentation 24
Insufficient Information 18
Material Integrity Problem 16
Device Contaminated During Manufacture or Shipping 7
Improper or Incorrect Procedure or Method 7
Loss of or Failure to Bond 7
Torn Material 6
Failure To Adhere Or Bond 5
Shelf Life Exceeded 5

Yearly Trend

05
2005: 2
10
2010: 2
13
2013: 20
14
2014: 97
15
2015: 243
16
2016: 59
17
2017: 26
18
2018: 221
19
2019: 67
20
2020: 137
21
2021: 57
22
2022: 71
23
2023: 115
24
2024: 35
25
2025: 84
26
2026: 33

Related Entities for Dressing, Wound, Hydrophilic

Top Manufacturers

CONVATEC DOMINICAN REPUBLIC INC 75
SMITH & NEPHEW MEDICAL LTD. 55

Event Locations

I 711 (56.0%)
518 (40.8%)
NO INFORMATION 33 (2.6%)
HOSPITAL 5 (0.4%)
HOME 2 (0.2%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Dressing, Wound, Hydrophilic, 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 (1,269 here).

Bone Mill 1,269 Agent, Occluding, Vascular, Permanent 1,271 Continuous Measurement Thermometer 1,271 Solid State X-Ray Imager 1,271

Similar death-typed counts

Nearest other device types by death-typed report count (6 here), distinct from the volume row.

Applicator, Absorbent Tipped, Non-Sterile 6 Cable, Electrode 6 Catheter, Straight 6 Device, Percutaneous Retrieval 6

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

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