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DeRoyal 9-418Recalls & reported problems

Deroyal Industries, Inc. · Laparotomy Sponges · 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 00749756025614), received between Apr 10, 2019 and Apr 10, 2019 — classified as 1 malfunction.

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

  • Break1
  • Material Fragmentation1
  • Material Integrity Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionApr 10, 2019Break; Material Fragmentation; Material Integrity Problem; Break; Material Fragmentation; Material Integrity Problem

    THE 4 X 4 GAUZE PACKAGED IN A CONVENIENCE KIT FELL APART DURING A PROCEDURE. THE PHYSICIANS HAD TO PICK PIECES OFF OF THE PATIENT BEFORE CLOSING.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8500813 ↗

Other GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices

All GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices →

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