Dermacea 441106Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10192253048704), received between Nov 3, 2025 and Nov 3, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionNov 3, 2025Material Fragmentation; Material Frayed; Material Fragmentation; Material Frayed

  THE CUSTOMER REPORTED THAT THE LARGE COTTON GAUZE/WRAP IS NOTICEABLY THINNER, PRONE TO FRAYING, AND LEAVING ROUGH EDGES THAT CAN CAUSE COTTON DEBRIS IN WOUNDS. BECAUSE OF ITS FRAGILITY, STAFF OFTEN NEED TO USE MORE PRODUCT TO ACHIEVE APPROPRIATE COVERAGE. ADDITIONAL INFORMATION RECEIVED ON 21OCT2025 STATED THAT THE WEAVES ON THIS BRAND ARE WIDE REQUIRING DOUBLE THE LAYERS. THE ROLLS FRAY ON THE ENDS AND MOST ESPECIALLY WHEN CUT CAUSING FRAGMENTS TO FALL OFF. THEY ARE NOT AWARE OF ANY SITUATION WHERE DEBRIS WAS IN A WOUND, BUT ARE CONCERNED IT COULD HAPPEN. THE ROLLS ARE USED IN BOTH A CLINICAL AND SURGICAL SETTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459006 ↗