OPSITE POST OP 9.5X8.5CM CTN 20 66000709Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05000223441241), received between Oct 14, 2020 and Jul 18, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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.

• InjuryJul 18, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER TREATMENTS HAD BEEN PERFORMED WITH FIVE (5) OPSITE POST OP 9.5X8.5CM CTN 20, MANY PATIENTS EXPERIENCED AN ALLERGIC REACTION. THE SURGEON HAS BEEN USING IT FOR ALMOST 10 YEARS WITHOUT AN ISSUE, BUT LATELY THEY HAVE SEEN A TREMENDOUS INCREASE IN PATIENTS WITH ALLERGIC REACTIONS TO THESE. MANY OF THESE PATIENTS HAVE HAD OPSITE POST OP PLACED BY THE SURGEON MANY TIMES IN THE PAST WITHOUT ANY ISSUE. ALL OF A SUDDEN, IN THE LAST FEW MONTHS, THESE PATIENTS ARE NOW GETTING SEVERE LOCAL REACTIONS. THIS ADVERSE EVENT WAS TREATED USING A COMPETITOR¿S DEVICE. THE CORRECT NUMBER OF AFFECTED PATIENTS AND THEIR CURRENT HEALTH STATUS REMAINS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22543328 ↗
• MalfunctionMay 27, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT, BEFORE THE PRODUCT WAS SENT TO A HEALTHCARE FACILITY, WAS FOUND THE OPSITE POST OP 9.5X8.5CM CTN 20 HAD A FOREIGN SUBSTANCE ON THE DRESSING. NO CASE INVOLVED; THEREFORE, NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11892759 ↗
• MalfunctionMay 6, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, A PURCHASE OF OPSITE POST OP PACKAGES, WAS IMMEDIATELY RETURN, BECAUSE THERE WAS NO ADHESIVE TO THE DRESSINGS, THEREFORE, THE DRESSINGS WOULD NOT STAY ON. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787893 ↗
• MalfunctionApr 15, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, CUSTOMER HAS HAD A CYST EXCISED AND DRAINED FROM HER BACK, NURSE APPLIED OPSITE DRESSING WHICH DID NOT STAY ON AND WAS LIFTING AROUND THE EDGES ALMOST STRAIGHT AWAY. CUSTOMER THEN WENT TO LOCAL CHEMIST TO HAVE THE DRESSING REPLACED WITH THE SAME TYPE OF S&N OPSITE POST OP DRESSING AND IS HAVING THE SAME PROBLEM WITH THE DRESSING NOT STICKING. CUSTOMER IS VERY CONCERNED AS SHE HAS AN OPEN WOUND ON HER BACK AND CAN'T SEE HER DOCTOR FOR RE-DRESSING UNTIL THE MORNING. THE CUSTOMER ALSO ADVISED THAT SHE EXPERIENCED THE SAME ISSUE 6 WEEKS AGO WITH THIS DRESSING FROM THE INITIAL SURGERY. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED AND IF THERE WAS A DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671074 ↗
• MalfunctionApr 15, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, CUSTOMER HAS HAD A CYST EXCISED AND DRAINED FROM HER BACK, NURSE APPLIED OPSITE DRESSING WHICH DID NOT STAY ON AND WAS LIFTING AROUND THE EDGES ALMOST STRAIGHT AWAY. CUSTOMER THEN WENT TO LOCAL CHEMIST TO HAVE THE DRESSING REPLACED WITH THE SAME TYPE OF S&N OPSITE POST OP DRESSING AND IS HAVING THE SAME PROBLEM WITH THE DRESSING NOT STICKING. CUSTOMER IS VERY CONCERNED AS SHE HAS AN OPEN WOUND ON HER BACK AND CAN'T SEE HER DOCTOR FOR RE-DRESSING UNTIL THE MORNING. THE CUSTOMER ALSO ADVISED THAT SHE EXPERIENCED THE SAME ISSUE 6 WEEKS AGO WITH THIS DRESSING FROM THE INITIAL SURGERY. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED AND IF THERE WAS A DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671057 ↗
• MalfunctionMar 22, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, CUSTOMER USED 1 OUT OF THE BOX AND FOUND THAT IT WAS NOT STICKING TO HER SKIN. THE CUSTOMER HAD CLEAN SKIN WITH NO MOISTURISING PRODUCTS ON THE SKIN PRIOR TO APPLICATION. NO DELAY WAS REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO OTHER COMPLICATIONS WHERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11547848 ↗
• MalfunctionMar 16, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE OPSITE POST OP IS NOT ADHERING TO SKIN. IT IS UNKNOWN IF A BACKUP WAS AVAILABLE TO CONTINUE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11498520 ↗
• MalfunctionOct 14, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT WHEN APPLIED TO CLEAN DRY SKIN AND AFTER 3 HOURS THE SIDES STARTED TO PEEL OFF AND DOES NOT STICK. UNKNOWN HOW THE PROCEDURE FINISHED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10681168 ↗