OPSITE POST OP 25X10CM CTN 20 66000714Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05000223441395), received between Dec 10, 2020 and May 5, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (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.

• InjuryMay 5, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A TKR PERFORMED ON (B)(6) 2022, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOLLOWING THE APPLICATION OF A NEW OPSITE POST OP 25X10CM DRESSING. WITHIN HOURS, SHE BEGAN TO EXPERIENCE A PAINFUL RASH AND AN INTENSE BURNING AND ITCHING SENSATION UNDER THE ADHESIVE PART OF THE DRESSING AND LATER MIGRATING ALL OVER HER BODY, ESPECIALLY ON HER ARMS AND LEGS. THE DRESSING WAS REMOVED, A STEROID CREAM AND ANTIHISTAMINE TABLETS WERE PRESCRIBED, BUT THE SYMPTOMS HAVE PERSISTED EVEN 2 WEEKS AFTER THE INITIAL REACTION. IN ADDITION, THE PATIENT HAS BEEN EXPERIENCING SWELLING OF BOTH LEGS, AND A SKIN APPEARANCE REPORTED AS TIGHT AND SHINY. BESIDES THESE SYMPTOMS, THE WOUND HAS HEALED EXTREMELY WELL AND VERY QUICKLY AND THE DOCTORS SAY THIS MUST BE A SEVERE ALLERGIC REACTION AND THAT IT WAS FROM THE ADHESIVE ON THE DRESSING WHERE THE IRRITATION STARTED.

  Patient problems: Ambulation or Postural Difficulties; Itching Sensation; Rash; Skin Burning Sensation; Swelling/ Edema

  MAUDE report 14291349 ↗
• MalfunctionDec 10, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING TREATMENT, WHEN OPENING THE OPSITE POST OP DRESSING, IT WAS OBSERVED THAT THE DRESSING WAS WITH THE GAUZE WITHOUT ADHERING TO THE FILM. IT IS UNKNOWN HOW THE TREATMENT WAS COMPLETED. NO PATIENT HARM OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10984522 ↗