DeRoyal 88-000202Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756142014), received between Sep 27, 2018 and Sep 27, 2018 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionSep 27, 2018Material Integrity Problem; Material Integrity Problem

  THE HYDROGEL ON THE GROUNDING PADS WAS DRIED UP. THE PADS DID NOT STICK TO THE PATIENT PROPERLY, AND IN ONE INCIDENT, THIS CAUSED BURNS TO THE PATIENT.

  Patient problems: Burn(s); Injury

  MAUDE report 7915524 ↗
• MalfunctionSep 27, 2018Material Integrity Problem; Material Integrity Problem

  THE HYDROGEL ON THE GROUNDING PADS WAS DRIED UP. THE PADS DID NOT STICK TO THE PATIENT PROPERLY, AND IN ONE INCIDENT, THIS CAUSED BURNS TO THE PATIENT.

  Patient problems: Burn(s); Injury

  MAUDE report 7915520 ↗