ACTICOAT FLEX3 4" X 4" 66800406Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00040565124810), received between Oct 12, 2021 and Dec 29, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, DURING LYMPHATIC AND VENOUS LEG ULCER THERAPY, THE PATIENT WAS TREATED WITH ACTICOAT FLEX3 ON ONE OF THE ULCERS AND WITH AN UNKNOWN DERMIGEL ON THE OTHER ONE. IN ADDITION, HAMUT CREAM WAS APPLIED ON THE WOUND BORDERS. ON (B)(6) 2023 THE PATIENT EXPERIENCED A SEVERE ALLERGIC REACTION WITH EYE AND MOUTH INFLAMMATION. BOTH THE ACTICOAT AND THE UNKNOWN GEL WERE IMMEDIATELY REMOVED. IT WAS UNSPECIFIED EXACTLY WHICH ADDITIONAL ACTIONS WERE REQUIRED, BUT THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM. EVEN THOUGH THE PATIENT WAS PREVIOUSLY TREATED WITH ACTICOAT FLEX3 A WEEK BEFORE WITHOUT ANY HEALTH IMPACT, IT IS UNCLEAR WHICH WAS THE CAUSE THIS REACTION. THE PATIENT REQUIRED MEDICAL CONTROL SUBSEQUENT TO THIS EVENT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation

  MAUDE report 18418218 ↗
• InjurySep 6, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT, DURING TREATMENT ONE (1) ACTICOAT FLEX3 10X10CM CTN OF 12 GOT STUCK IN THE PATIENT WOUND AND IT WAS ABSORBED. THE PROBLEM WAS NOT SOLVED. THE ITEM IS STILL STUCK ON THE BED AND WILL BE REMOVED SURGICALLY BY THE DOCTOR. NO OTHER COMPLICATION REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17690733 ↗
• InjuryOct 12, 2021Cross Reactivity; Cross Reactivity

  IT WAS REPORTED THAT, DURING WOUND TREATMENT, OVER 12 DAYS OF USE THE PATIENT EXPERIENCED PAIN HAD INCREASED TO THE POINT THAT PATIENT FOUND IT DIFFICULT TO MOVE HER LEG. WHEN DAUGHTER CHANGED THE DRESSING SEVERE REDNESS AND SWELLING NOTED TO LOWER LIMB. PATIENT REPORTED PAIN DURING ALL APPLICATIONS, WHICH PERSISTED OVER THE 12 DAYS. ACTICOAT FLEX 3 WAS CUT TO SIZE OF WOUND. ALSO PATIENT REPORTED THAT THE HOLES IN HER LEG WERE BIGGER AFTER THE ACTICOAT FLEX 3 WAS USED. THIS ADVERSE EVENT WAS TREATED BY CHANGING THE DRESSING TO AQUACEL AG. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN..

  Patient problems: Contact Dermatitis; Inflammation; Swelling/ Edema

  MAUDE report 12615485 ↗