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DeRoyal 30-056Recalls & reported problems

Deroyal Industries, Inc. · Neuro Sponges · Class U

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 00749756254243), received between Mar 5, 2021 and Mar 5, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity 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

  • Material Integrity Problem1
  • Material Separation1
  • Protective Measures Problem1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • MalfunctionMar 5, 2021Material Separation; Material Integrity Problem; Protective Measures Problem; Material Separation; Material Integrity Problem; Protective Measures Problem

    A NEURO SPONGE MISCOUNT OCCURRED. THE SPONGE WAS NOT DETECTED DURING AN X-RAY. THE DOCTOR WENT INTO THE OPERATIVE SITE, FOUND THE SPONGE, AND REMOVED IT.

    Patient problems: Foreign Body In Patient

    MAUDE report 11423705 ↗

Other GAUZE/SPONGE, INTERNAL devices

All GAUZE/SPONGE, INTERNAL devices →

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