OPSITE POST OP 6.5X5CM CTN 100 66000708Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05000223441210), received between Nov 27, 2020 and Mar 29, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 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.

• MalfunctionMar 29, 2022Contamination; Contamination

  IT WAS REPORTED THAT, DURING SET UP FOR WOUND TREATMENT, IT WAS CONFIRMED THERE WAS A FOREIGN SUBSTANCE ON THE WOUND-CONTACT SIDE OF THREE DRESSINGS OF A OPSITE POST OP 6.5X5CM CTN 100. AS THIS WAS NOTICED BEFORE TREATMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13945792 ↗
• MalfunctionNov 6, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT, DURING THE SET UP FOR A WOUND TREATMENT, IT WAS NOTICED THAT THERE WAS A BLACK 2×1MM FOREIGN SUBSTANCE BETWEEN THE FILM AND THE PAD OF THE DRESSINGS FROM A OPSITE POST OP 6.5X5CM CTN 100 BOX. TREATMENT WAS PERFORMED WITHOUT ANY DELAY, WITH A BACK UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12755725 ↗
• MalfunctionJun 23, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT, DURING THE SET UP OF A WOUND DRESSING TREATMENT, AN OPSITE POST OP 6.5X5CM CTN 100 HAD A FOREIGN SUBSTANCE ON THE PAD, SO IT WAS NOT USED. THIS HAPPENED BEFORE USE IN PATIENT. THE 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 12049993 ↗
• MalfunctionJan 27, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, WHEN USING A OPSITE POST OP 6.5X5CM CTN 100, THE DRESSING DID NOT STICK. NO OTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11238428 ↗
• MalfunctionNov 27, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DRESSING WAS NOT STICKING AND FELL OFF. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10915117 ↗