Opsite Incise 55x45cm Ctn 10 4989Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05000223415525), received between May 14, 2021 and Jul 5, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, THE SEALING OF AN OPSITE INCISE 55X45CM CTN 10 WAS BROKEN BEFORE USE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A THERAPEUTIC ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17263618 ↗
• MalfunctionMay 12, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING SET UP FOR TREATMENT, THE STERILE PACKAGE OF A OPSITE INCISE 55X45CM CTN 10 WAS FOUND NOT PROPERLY SEALED BEFORE GIVING IT USE; THE SEALING WAS FOUND INCOMPLETE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP OPSITE INCISE 55X45CM. SINCE THE INCIDENT OCCURRED BEFORE THE PROCEDURE; THE PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16917377 ↗
• MalfunctionMay 14, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING TREATMENT THE STERILE POUCH OF A OPSITE INCISE 55X45CM CTN 10 OPENED EASILY AND WITH SMALL STRENGTH THAN USUAL. THE OPSITE INCISE 55X45CM CTN 10 WAS NOT USED FOR TREATMENT BECAUSE IT WAS IN QUESTION THE SEALING INTEGRITY OF THE POUCH. THE TREATMENT WAS COMPLETED WITHOUT DELAY AND IT IS UNKNOWN HOW THE TREATMENT WAS RESUME. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11828746 ↗