DeRoyal 89-3865Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756568043), received between Jan 22, 2020 and Feb 25, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 16, 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.

• MalfunctionFeb 25, 2020Defective Device; Manufacturing, Packaging or Shipping Problem; Defective Device; Manufacturing, Packaging or Shipping Problem

  AS THE SCRUB WAS COVERING THE MAYO STAND WITH THE MAYO STAND COVER FROM THE CONVENIENCE KIT, IT WAS NOTED THAT THE END OF THE MAYO STAND COVER WAS OPEN INSTEAD OF BEING SEALED. THUS, THE SCRUB INADVERTENTLY CONTAMINATED HERSELF IN THE PROCESS OF PLACING THE MAYO STAND COVER ON THE MAYO STAND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9752881 ↗
• MalfunctionJan 22, 2020Contamination /Decontamination Problem

  AS SHE WAS COVERING THE MAYO STAND WITH THE MAYO STAND COVER FROM THE PACK IT WAS NOTED THAT THE END OF THE MAYO STAND COVER WAS OPEN INSTEAD OF BEING SEALED, THUS THE SCRUB INADVERTENTLY CONTAMINATED HERSELF IN THE PROCESS OF PLACING THE MAYO STAND COVER ON THE MAYO STAND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9615709 ↗