Medical Action Industries 58193Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10809160008195), received between Mar 9, 2021 and Mar 9, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2021Component Misassembled; Material Split, Cut or Torn

  WHILE COMPLETING A DRESSING CHANGE ON A PATIENT A DEFECT WITH THE TEGADERM W//CHG WAS DISCOVERED ON THE KIT WITH LOT #279271. THE RN NOTICED SEVERAL CUTS AROUND THE EDGES OF DRESSING AND AFTER PEELING THE BACK PAPER TO APPLY TO PATIENT, THE STICKY SIDE WAS FACED UPWARD. WE LOOK AT ALL DRESSING IN BOTH SUPPLY ROOMS THIS WAS THE ONLY KIT WITH LOT # 279271. MOST ALL OTHERS WERE LOT #275593 AND THESE DRESSINGS APPEAR TO BE FINE.

  Patient problems: Insufficient Information

  MAUDE report 11445299 ↗