OPSITE INCISE 15X28CM CTN 10 4986Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05000223415495), received between Dec 18, 2020 and Mar 7, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, IT WAS IMPOSSIBLE TO REMOVE THE RELEASE PAPER OF THE OPSITE BECAUSE IT ADHERED TO THE FILM STRONGLY. THE PROCEDURE WAS COMPLETED WITHOUT A SIGNIFICANT DELAY USING A SMITH & NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11429734 ↗
• InjuryDec 18, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE DR. INFORMED THAT LATELY THE QUALITY OF THE OPSITE INCISE IS NOT GOOD SINCE IT IS NOT STICKING PROPERLY TO THE SKIN AT THE MOMENT OF SURGERY. IT COMES OUT OF THE SKIN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A DELAY. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11039867 ↗