ACTICOAT 16"X16" 20401Recalls & reported problems
Smith & Nephew Medical Limited · Silver-coated antimicrobial barrier dressing · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05000223449858), received between Nov 1, 2023 and Mar 21, 2024 — classified as 3 injuries.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Impaired Healing2
- Skin Erosion2
- Bacterial Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, DURING TREATMENT FOR PETROL FLAME BURNS, AN ACTICOAT 40X40CM CTN 6 DRESSING WAS APPLIED ALONG WITH A COMPETITOR'S PRODUCT (MEPITEL) AND THE PATIENT WAS DISCHARGED HOME. ON DAY #3 POST-INJURY, THE BURN HAD PROGRESSED AND A LARGE AMOUNT OF DEVITALIZED SKIN WAS REMOVED. BOTH ACTICOAT AND MEPITEL WERE APPLIED AGAIN. EVEN THOUGH BY DAY #8 SOME AREAS WERE HEALED, ON DAY #12 DEEPER AREAS WERE SLOUGHY WITH SLIMY EXUDATE. THIS EVENT WAS REVIEWED BY A PLASTIC SURGEON AND FLAMAZINE WAS APPLIED. WOUND SWABS WERE TAKEN, WHICH REVEALED BACTERIAL GROWTH (STREP A AND STAPH AUREUS). THE WOUNDS SUBSEQUENTLY CLEARED UP AFTER SSD AND SILVER FOAM APPLICATION.
Patient problems: Bacterial Infection
MAUDE report 18956640 ↗InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, FOLLOWING ARM BURNS, THE PATIENT WAS TREATED WITH ACTICOAT 40X40CM CTN 6, WHICH CAUSED PSEUDO-ESCHAR TO FORM ON THE BURN SITE. TREATMENT WAS PRESCRIBED AS A CLASSIC THREE-DAY COURSE INVOLVING MOISTENING WITH WATER (EITHER WATER-SOAKED GAUZE, INTRASITE CONFORMABLE MATERIAL OR HYPAFIX AND MOISTENING THREE TIMES A DAY) AS WELL AS WOUND DEBRIDEMENT OR AUTOLYTIC DEBRIDEMENT TO CLEAN UP, HOWEVER, THE ISSUE BECAME WORSE WITH THE PRODUCT. IT IS UNCLEAR WHAT THE PATIENT'S CURRENT HEALTH STATUS IS AND HOW THE TREATMENT WAS FINISHED.
Patient problems: Impaired Healing; Skin Erosion
MAUDE report 18049601 ↗InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, FOLLOWING UPPER BODY BURNS CAUSED BY HOT OIL, THE PATIENT WAS TREATED WITH ACTICOAT 40X40CM CTN 6, WHICH CAUSED PSEUDO-ESCHAR TO FORM ON THE BURN SITE. TREATMENT WAS PRESCRIBED AS A CLASSIC THREE-DAY COURSE INVOLVING MOISTENING WITH WATER (EITHER WATER-SOAKED GAUZE, INTRASITE CONFORMABLE MATERIAL OR HYPAFIX AND MOISTENING THREE TIMES A DAY), AS WELL AS WOUND DEBRIDEMENT OR AUTOLYTIC DEBRIDEMENT TO CLEAN UP, HOWEVER, THE ISSUE BECAME WORSE WITH THE PRODUCT. IT IS UNCLEAR WHAT THE PATIENT'S CURRENT HEALTH STATUS IS AND HOW THE TREATMENT WAS FINISHED.
Patient problems: Impaired Healing; Skin Erosion
MAUDE report 18049508 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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