DeRoyal 89-5320Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756632836), received between Oct 30, 2020 and Oct 30, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 30, 2020Contamination; Device Contamination with Body Fluid; Contamination /Decontamination Problem; Contamination; Device Contamination with Body Fluid; Contamination /Decontamination Problem

  A SURGICAL GOWN PACKAGED IN A CONVENIENCE KIT ALLOWED STRIKE THROUGH. THE PATIENT'S BODILY FLUIDS WERE ON THE PHYSICIAN'S ARM AND SOAKED THROUGH THE SCRUB SLEEVE. THE PATIENT IS HEPATITIS C POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10765548 ↗