OPSITE POST OP 15.5X8.5CM CTN 20 66000712Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05000223441333), received between Sep 30, 2020 and Sep 22, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2025Loss of or Failure to Bond; Difficult to Remove; Biocompatibility; Loss of or Failure to Bond; Difficult to Remove; Biocompatibility

  IT WAS REPORTED THAT DURING A WOUND TREATMENT FOR A SURGERY THAT TOOK PLACE IN JUNE THE PATIENT EXPERIENCED A SEVERE SKIN ALLERGIC REACTION INCLUDING BLISTER FORMATION ONLY WHERE THE COMPRESS WAS, NOT THE TRANSLUCENT PLASTIC. AFTER A FEW DAYS OF APPLYING A DRESSING OF ONE (1) OPSITE POST OP 15.5X8.5CM CTN 20, IT REPORTEDLY ALSO CAME LOOSE AND STUCK TO THE SKIN. THE TREATMENT WAS COMPLETED AFTER A SIGNIFICANT SURGICAL TREATMENT DELAY USING EQUIVALENT S+N BACKUP PRODUCTS. THE PATIENT¿S CURRENT HEALTH STATUS AND HOW THE EVENT WAS ADDRESSED IS UNKNOWN.

  Patient problems: Blister; Hypersensitivity/Allergic reaction

  MAUDE report 23106591 ↗
• MalfunctionMar 28, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, IT WAS NOTICED THAT THE ADHESIVE OF OPSITE POST OP DRESSINGS WAS WEAK SO THE RELEASE PAPER WAS SEPARATED, AND THE FILM PART WAS STICKING TO THE WRAPPING PAPER. FROM (B)(4): 3 DRESSINGS PRESENTED THE FAILURE MODE. (B)(4): CUSTOMER SAID THAT DRESSINGS HAD THE REPORTED PROBLEM AND THOSE WERE ALREADY DISCARDED. NO CASE INVOLVED; THEREFORE, NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580349 ↗
• MalfunctionMar 28, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, IT WAS NOTICED THAT THE ADHESIVE OF OPSITE POST OP DRESSINGS WAS WEAK SO THE RELEASE PAPER WAS SEPARATED, AND THE FILM PART WAS STICKING TO THE WRAPPING PAPER. FROM (B)(4): 3 DRESSINGS PRESENTED THE FAILURE MODE. (B)(4): CUSTOMER SAID THAT DRESSINGS HAD THE REPORTED PROBLEM AND THOSE WERE ALREADY DISCARDED. NO CASE INVOLVED; THEREFORE, NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580348 ↗
• MalfunctionFeb 23, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, IT WAS NOTICED THAT THE ADHESIVE OF OPSITE POST OP DRESSINGS WAS WEAK SO THE RELEASE PAPER WAS SEPARATED, AND THE FILM PART WAS STICKING TO THE WRAPPING PAPER. 3 DRESSINGS PRESENTED THE FAILURE MODE. NO CASE INVOLVED; THEREFORE, NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364403 ↗
• InjurySep 30, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE OPSITE DRESSING HAD A FOREIGN BODY STUCK TO THE PRODUCT. AFTER PASTING THE DRESSING ON THE PATIENT SKIN THE NURSE IDENTIFIED THAT THE FOREIGN BODY WAS A MOSQUITO. CUSTOMER CHOOSE TO CONTINUE USING THE PRODUCT. THE MOSQUITO WAS STUCK BETWEEN COTTON AND PLASTIC. NO ADVERSE EVENTS OR INJURIES HAVE BEEN REPORTED AS A RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10610261 ↗