Dermacea 441000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521066038), received between Aug 30, 2022 and Aug 30, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Frayed” (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.

• MalfunctionAug 30, 2022Material Frayed; Material Frayed

  THE CUSTOMER REPORTED THAT THE GAUZE IS FRAYING WHEN USED. ADDITIONAL INFORMATION RECEIVED STATED THAT THE GAUZE WAS USED IN THE OPERATING ROOM AND DELIVERY ROOM. WHEN THE DOCTORS USE IT AND REMOVE IT FROM WHERE THEY PLACE IT IN THE PATIENT, THE THREAD COMES OUT AND THE GAUZE FRAYS LITTLE BY LITTLE; THE THREAD DOESN¿T COME OUT COMPLETELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15319254 ↗