OPSITE FLEXIFIX 10CMX10M 66000041Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05000223411473), received between Sep 9, 2020 and Mar 8, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT, IT WAS DIFFICULT TO TAKE AN OPSITE FLEXIFIX 10CMX10M CTN 1 OUT OF THE CARTON BECAUSE SIDE-EDGES OF THE FILM ROLL HAS ADHERED TO INSIDE THE CARTON. AS THIS WAS NOTICED IN A NON-THERAPEUTIC ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690823 ↗
• MalfunctionOct 19, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHEN THE PRODUCT WAS TAKEN OUT OF THE CARTON, IT WAS CONFIRMED THE PRODUCT WAS STICKY SO IT COULD NOT BE USED. A BACKUP WAS AVAILABLE. NO DELAY OR HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661227 ↗
• MalfunctionSep 28, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT, DURING A TREATMENT SETUP, AN OPSITE FLEXIFIX 10CMX10M CTN 1 WAS IMPOSSIBLE TO UNROLL BECAUSE A PART OF THE RELEASE PAPER HAS BEEN ADHERED TO THE TRANSPARENT CARRIER OF INSIDE PART OF THE ROLL, DUE TO EXCESSIVE ADHESIVE ON THE BACKSIDE OF THE RELEASE PAPER. TREATMENT WAS COMPLETED WITH A BACKUP DEVICE. NO DELAY WAS REPORTED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544884 ↗
• MalfunctionSep 21, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT WHEN THE SEPARATION OF THE OPSITE FLEXIFIX 10CMX10M CTN 1 WAS INITIATED, TO SEND THE PATIENT TO THE RESIDENT, THE PRODUCT WAS FOUND TO HAVE THE BACK OF THE DRESSING ADHERED TO THE ROLLER, WHEN TRYING TO REMOVE IT, THE PRODUCT BEGAN TO GET DAMAGED. NO DELAY TO THE TREATMENT REPORTED OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12509990 ↗
• MalfunctionMay 4, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION THE OPSITE FLEXIFIX 10CMX10M CTN 1 WAS CREASED.THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE.NO CASE INVOLVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773627 ↗
• MalfunctionJan 19, 2021Failure to Unfold or Unwrap; Material Integrity Problem; Failure to Unfold or Unwrap; Material Integrity Problem

  IT WAS REPORTED THAT, THE OPSITE FILM IS ROLLED TOO TIGHTLY, AND IT CAN'T BE UNROLLED PROPERLY. SOMETIMES IT STICKS TO THE INSIDE OF THE BOX AND THE PACKAGING HAS TO BE DISPOSED OF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A COMPETITOR DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197619 ↗
• MalfunctionSep 9, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT IN OPSITE FLEXIFIX 10CM X 10CM, CTN 1, A DECOLORATION IN THE PROTECTIVE BACKING WAS FOUND, ALSO THE TAPE APPEARS MORE FLIMSY AND EDGES CURL CAUSING LIFTING AND IN BOTH OCCASIONS LEAKING OF UROSTOMY. THERE WAS NO CHANGES IN UROSTOMY OUTPUT, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME DEVICE. NO PATIENT INJURY, DELAY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10511614 ↗
• MalfunctionSep 9, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT IN OPSITE FLEXIFIX 10CM X 10CM, CTN 1, A DISCOLORATION IN THE PROTECTIVE BACKING WAS FOUND, ALSO THE TAPE APPEARS MORE FLIMSY AND EDGES CURL CAUSING LIFTING AND IN BOTH OCCASIONS LEAKING OF UROSTOMY. THERE WAS NO CHANGES IN UROSTOMY OUTPUT, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME DEVICE. NO PATIENT INJURY, DELAY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10511565 ↗