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DURAFIBER 15X15 CTN 5 66800561Recalls & reported problems

Smith & Nephew Medical Limited · Absorbent gelling fibrous dressing · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05000223466725), received between Jun 22, 2021 and Jun 22, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unsealed Device Packaging” (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

  • Unsealed Device Packaging1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 22, 2021Unsealed Device Packaging; Unsealed Device Packaging

    IT WAS REPORTED THAT A DURAFIBER'S PACKAGING WAS NOT COMPLETELY SEALED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12042960 ↗

Other Dressing, Wound, Hydrophilic devices

All Dressing, Wound, Hydrophilic devices →

Sources and updates

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