ALGISITE M 2X2" CTN 10 59480100Recalls & 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
- 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 05000223425074), received between Mar 16, 2021 and Nov 1, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Open or Remove Packaging Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Purulent Discharge1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON THE LITERATURE ARTICLE NAMED "CLINICAL EFFECT OF THIN COMBINED WITH CALCIUM ALGINATE DRESSING IN PREVENTING EARLY COMPLICATIONS AFTER PICC CATHETERIZATION IN ELDERLY TUMOR PATIENTS", IT WAS REPORTED THAT, WHEN USING A COMBINATION OF AN ALGISITE AND ALLEVYN THIN DRESSINGS APPLIED ON A PCC CATHETER INSERTION SITE FOR TUMOR TREATMENT IN ELDERLY PATIENTS, THE PUNCTURE SITE OF ONE PATIENT BECAME INFLAMED AND INFECTED, AS THERE WAS A PURULENT DISCHARGE PRESENT. ADDITIONAL DETAILS ON HOW THIS ADVERSE EVENT WAS TREATED ARE UNKNOWN. THE PATIENT OUTCOME IS UNKNOWN.
Patient problems: Purulent Discharge; Unspecified Infection
MAUDE report 12733692 ↗InjuryMar 16, 2021Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
IT WAS REPORTED THAT THE ALGISITE DRESSING WAS ADHERED TO THE BACK BAG. AND THERE WAS MATERIAL LEFT ON THE BAG WHEN THE DRESSING WAS TAKEN OFF BY HAND. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S PRODUCT WITH A SMALL DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11493213 ↗
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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