DeRoyal 28-0101BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756301749), received between Feb 7, 2019 and Dec 18, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2019Break; Material Fragmentation; Material Integrity Problem; Break; Material Fragmentation; Material Integrity Problem

  PORTIONS OF THE FOAM PAD PACKAGED WITH THE ANTI-FOG SOLUTION PEELED AWAY AND FEEL OFF OF THE BACKING. THIS CREATED THE POTENTIAL FOR A RETAINED OBJECT IN THE PATIENT. THE NURSE NOTICED PART OF THE FOAM WAS MISSING AND WAS ABLE TO LOCATE THE SECTION THAT FELL OFF IN THE FIELD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9491961 ↗
• MalfunctionFeb 7, 2019Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem

  THE X-RAY DETECTABLE STRIP CAME OFF THE ANTI-FOG PAD DURING A PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8317853 ↗