Skip to content

DeRoyal 26-002Recalls & reported problems

Deroyal Industries, Inc. · Surgical Skin Markers · Class 1

Data updated Oct 16, 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 00749756157483), received between Nov 29, 2018 and Nov 29, 2018 — classified as 1 malfunction.

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

Device problems

  • Biocompatibility1
  • Patient Device Interaction Problem1
  • Patient-Device Incompatibility1

Patient problems

  • Edema1
  • Itching Sensation1
  • Skin Irritation1

Recent adverse event reports

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

  • MalfunctionNov 29, 2018Patient-Device Incompatibility; Biocompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Biocompatibility; Patient Device Interaction Problem

    AN END USER REPORTED AN INCIDENT OF ALLERGIC REACTION RIGHT AFTER SURGERY. A TYPE 1 RESPONSE AND TYPE 4 RESPONSE WERE REPORTED.

    Patient problems: Edema; Itching Sensation; Skin Irritation

    MAUDE report 8116867 ↗

Other Kit, surgical instrument, disposable devices

All Kit, surgical instrument, disposable devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page