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DeRoyal 89-6867Recalls & reported problems

Deroyal Industries, Inc. · MAJOR PACK CSM · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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 00749756731317), received between Feb 7, 2019 and Feb 7, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fire” (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

  • Fire1
  • Temperature Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionFeb 7, 2019Fire; Temperature Problem; Fire; Temperature Problem

    THE CONVENIENCE KIT CONTAINED A CAUTERY DEVICE THAT CAUGHT ON FIRE WHILE THE RESIDENT WAS HOLDING IT. THIS OCCURRED RIGHT AFTER USE ON A PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8316752 ↗

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Sources and updates

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