ACTICOAT FLEX7 4" X 5" 66800405Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00040565124339), received between Oct 29, 2020 and Nov 1, 2023 — classified as 2 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 Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Reaction1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AN ACTICOAT FLEX 7 10X12.5CM CTN 5 WAS CUT INTO A STRIP AND USED FOR TUNNELING OF WOUND AS A PACKING MATERIAL. WHEN THE WOUND WAS X-RAYED TO CONFIRM PACKING MATERIAL WAS REMOVED, THE AMOUNT OF ACTICOAT DOCUMENTED IN THE WOUND DID NOT SHOW ON X RAY. THEREFORE THEY HAD TO ORDER A CT SCAN TO CONFIRM IT WAS STILL IN PLACE. IT SHOWED UP ON CT SCAN BUT NOT AN X RAY. PATIENT REQUIRED SURGERY TO REMOVE DRESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18049665 ↗InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD ACTICOAT FLEX APPLIED TO LEG WOUND WHICH HAD INSTANT STINGING SENSATION. A RENASYS FOAM DRESSING WAS APPLIED OVER THE TOP AND CONNECTED TO RENASYS DEVICE AT 80MMGH PRESSURE ON CONTINUES SETTING. PATIENT COMPLAINED IT WAS LIKE A CHEMICAL BURNING SENSATION. THE DRESSING WAS IN PLACE FOR 5 MINUTES AND STINGING SENSATION DID NOT SUBSIDE, THEN THE DRESSING WAS REMOVED. THE SEAL BROKE ON RENASYS DRESSING, THIS WAS LEFT FOR 2 MIN AND THEN REMOVED BUT THE WOUND WAS HIGHLY INFLAMED AND SLIGHT BLEEDING BUT NOT ACTIVE. BLEEDING SETTLED QUICKLY. THE ACTICOAT FLEX HAD BEEN USED FOR THE PAST 2 ½ WEEKS PRIORS TO THIS SUSPECTED REACTION. TREATMENT WAS SOLVED BY REPLACING THE DRESSINGS WITH CUTACERIN AND PICO.
Patient problems: Reaction
MAUDE report 10754363 ↗
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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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