Curity 6114Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521068629), received between Jan 26, 2021 and Jan 26, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inadequate Lubrication” (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 16, 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.

• MalfunctionJan 26, 2021Inadequate Lubrication; Inadequate Lubrication

  THE CUSTOMER REPORTED THAT THE GAUZE ADHERES TO THE WOUND BED CAUSING TRAUMA, PAIN AND BLEEDING UPON REMOVAL, IN ADDITION TO DESTROYING THE GRANULATION TISSUE ALREADY FORMED. FOR THIS REASON, THEY APPLY PURE PETROLEUM JELLY ON THE PRODUCT TO KEEP THE MOISTURE AND TO ENSURE THAT THE GAUZE DOES NOT ADHERE TO THE SKIN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 11233392 ↗