ALGISITE M 6X8" CTN 10 59480300Recalls & reported problems
Smith & Nephew Medical Limited · Calcium Alginate Wound Dressing · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05000223425241), received between Apr 19, 2021 and Apr 19, 2021 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Skin Burning Sensation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PRIVATE NURSE APPLIED AN ALGISITE M 15CM X 20CM DRESSING TO A PATIENT. THE DRESSING WAS TO BE APPLIED FOR 2 DAYS BUT THE PATIENT REMOVED THE DRESSING HERSELF AS SHE HAD BURNING SENSATIONS. SHE USED A CONVATEC AQUACEL EXTRA DRESSING INSTEAD. THE PATIENT WAS ALLERGIC TO IODINE. THE INSTRUCTIONS STATE: DO NOT USE ON PATIENTS WITH A KNOWN ALLERGY TO ANY OF THE COMPONENTS. THE NURSE WANTS TO KNOW IF THE DRESSING CONTAINS IODINE. THE ALLERGY STOPPED AS SOON AS THE DRESSING WAS REMOVED.
Patient problems: Skin Burning Sensation
MAUDE report 11684619 ↗
Other Dressing, Wound, Hydrophilic devices
- MEDLINE INDUSTRIES, INC. MSC7044EPMedline Industries, Inc. · Dressing, wound, hydrophilic1 recall1 report
- McKesson Reinforced AlginateAdvanced Medical Solutions Limited · Dressing, Wound, Hydrophilic1 recall0 reports
- McKesson 3561Mckesson Medical-Surgical Inc. · Dressing, Wound, Hydrophilic1 recall0 reports
- McKesson 3563Mckesson Medical-Surgical Inc. · Dressing, Wound, Hydrophilic1 recall0 reports
- McKesson 87400Mckesson Medical-Surgical Inc. · Dressing, Wound, Hydrophilic1 recall0 reports
- DuPad® 87810Derma Sciences Canada Inc · Dressing, wound, hydrophilic1 recall0 reports
- MAXORB EXTRA AlginateMedline Industries, Inc. · Dressing, Wound, Hydrophilic1 recall0 reports
- McKesson 3562Mckesson Medical-Surgical Inc. · Dressing, Wound, Hydrophilic1 recall0 reports
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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