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DeRoyal 30-321Recalls & reported problems

Deroyal Industries, Inc. · UNDERCAST PADDING · 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 00749756024389), received between May 13, 2021 and May 13, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Obtain Sample” (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

  • Appropriate Device Problem Term/Code Not Available1
  • Failure to Obtain Sample1

Patient problems

  • Rash1
  • Skin Disorders1
  • Skin Inflammation/ Irritation1

Recent adverse event reports

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

  • MalfunctionMay 13, 2021Failure to Obtain Sample; Appropriate Device Problem Term/Code Not Available; Failure to Obtain Sample; Appropriate Device Problem Term/Code Not Available

    PATIENT HAD A POST OPERATION SKIN REACTION.

    Patient problems: Rash; Skin Disorders; Skin Inflammation/ Irritation

    MAUDE report 11821197 ↗

Other BANDAGE, CAST devices

All BANDAGE, CAST devices →

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