ALLEVYN TRACHEOSTOMY 66027640, 66007640Recalls & reported problems
Smith & Nephew Medical Limited · ALLEVYN TRACHEOSTOMY 3.5X3.5" CTN 10 · 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 05000223415860), received between Apr 19, 2022 and Apr 19, 2022 — classified as 1 injury.
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
Device problems
- Biocompatibility1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 19, 2022Biocompatibility; Biocompatibility
IT WAS REPORTED THAT DURING TREATMENT THE PATIENT HAD A SEVERE ALLERGIC REACTION TO ALLEVYN TRACH DRESSING. THIS ADVERSE EVENT WAS RESOLVED BY SUPPLYING EPINEPHRINE X2 AND BENADRYL X1 AND REMOVING THE DRESSING. CURRENT HEALTH STATUS OF THE PATIENT IS OK.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 14153877 ↗
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- DUODERM 187662Convatec, Purchasing Department · Dressing, Wound, Occlusive43 reports
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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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