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DeRoyal 89-10548Recalls & reported problems

Deroyal Industries, Inc. · DENTAL PACK · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756363372), received between Apr 18, 2023 and Apr 18, 2023 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Contamination /Decontamination Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 18, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

    UNKNOWN FOREIGN DEBRIS FOUND INSIDE THE PACK ON THE SHARPS BOX.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16762643 ↗

Other General purpose dental tray devices

All General purpose dental tray devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.