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DeRoyal 31-249Recalls & reported problems

Deroyal Industries, Inc. · Procto Swabs · 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 00749756028615), received between Feb 5, 2020 and Feb 5, 2020 — 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

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.

  • MalfunctionFeb 5, 2020Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem

    THE COTTON END OF A SWAB BROKE OFF AND STAYED STUCK INSIDE OF PATIENT DURING DISINFECTION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9673511 ↗

Other APPLICATOR, ABSORBENT TIPPED, STERILE devices

All APPLICATOR, ABSORBENT TIPPED, STERILE devices →

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