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.
FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4018 (General, Plastic Surgery panel).
FDA MAUDE casebook
openFDA event book Dressing, Wound, Hydrophilic LIGHT-BOOK · MAUDE
#589 of 1000 · 1,397 reports · 2005–2026
- BOOK 1,397 reports
- RANK #589 of 1000
- DEATH 6 death-typed
- INJ 305 injury-typed
- MALF 1,080 malfunction
- SPAN 2005–2026
- PEAK 2015: 243
- PHOTO Dura Substitute
Nearest event-volume peer: Dura Substitute (0 report gap)
Dressing, Wound, Hydrophilic sits #589 of 1000 among tracked device types with 1,397 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 →
Malfunction reports run above the device-type norm
Dressing, Wound, Hydrophilic carries 77.3% MALFUNCTION-coded reports, 12.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
- INJ 21.8% corpus 30.3% · below corpus mean (-8.5 pp)
- MALF 77.3% corpus 64.8% · above corpus mean (+12.5 pp)
Lead product-problem code Delivered as Unsterile Product is 28% of coded problems · Lead manufacturer CONVATEC DOMINICAN REPUBLIC INC accounts for 58% of manufacturer-tagged reports · Top event location I is 51% of location-tagged rows .
Dressing, Wound, Hydrophilic in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Locator
Locator, Root Apex
1,412 reports
- Unit
Unit, Operative Dental
1,407 reports
- Sacroiliac Jo…
Sacroiliac Joint Fixation
1,406 reports
- Lens
Lens, Intraocular, Accommodative
1,402 reports
- Dressing (this)
Dressing, Wound, Hydrophilic
1,397 reports
- Dura Substitu…
Dura Substitute
1,397 reports
What this shows Dressing, Wound, Hydrophilic carries 1,397 MAUDE reports, ranked #589 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (84) held close to the prior two-year average of 75.
Related Entities for Dressing, Wound, Hydrophilic
Top Manufacturers
Event Locations
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, Hydrophilic: 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 (1,397 here).
Similar death-typed counts
Nearest other device types by death-typed report count (6 here), distinct from the volume row.
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.