OPSITE FLEXIFIX 5CMX10M 66000040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05000223411466), received between Apr 6, 2021 and Aug 31, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING SET UP FOR TREATMENT, WHEN ONE (1) OPSITE FLEXIFIX 5CMX10M CTN 1 WAS TAKEN OUT OF THE CARTON, IT WAS CONFIRMED THERE WERE A LOT OF HOLES IN LINE ON THE FILM. TREATMENT WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17667614 ↗
• MalfunctionDec 10, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT, DURING SET UP FOR TREATMENT, AN OPSITE FLEXIFIX 5CMX10M CTN 1 WAS IMPOSSIBLE TO UNROLL BECAUSE THERE WAS SOME ADHESIVE ON THE BACKSIDE OF THE RELEASE PAPER. WHEN THE CUSTOMER TRIED TO UNROLL TO USE, THE RELEASE PAPER WAS TORN UP. TREATMENT WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12974534 ↗
• MalfunctionNov 4, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, DURING A TREATMENT SETUP, WHEN AN OPSITE FLEXIFIX 5CMX10M CTN 1 WAS REMOVED FROM THE CARTON, IT WAS CONFIRMED THAT THE CARRIER PEELED OFF THE EDGE A FEW DOZEN CENTIMETERS. TREATMENT WAS COMPLETED WITH A BACKUP DEVICE, WITHOUT ANY DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752666 ↗
• MalfunctionApr 6, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT AN OPSITE FLEXIFIX WAS APPLIED OVER WOUND FROM CARPAL TUNNEL SURGERY AND IT WAS NOT STICKING PROPERLY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO DELAY REPORTED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617690 ↗