DeRoyal 50-11068Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00749756150149), received between Oct 26, 2021 and Oct 26, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2021Loss of or Failure to Bond; Material Integrity Problem; Loss of or Failure to Bond; Material Integrity Problem

  THE SPONGE ON THE STICK FROM THE KIT CAME OFF WHEN INSIDE A PATIENT. THEY HAVE TO REMOVE IT FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698584 ↗
• MalfunctionOct 26, 2021Loss of or Failure to Bond; Material Integrity Problem; Loss of or Failure to Bond; Material Integrity Problem

  THE SPONGE ON THE STICK FROM THE KIT CAME OFF WHEN INSIDE A PATIENT. THEY HAVE TO REMOVE IT FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698579 ↗
• MalfunctionOct 26, 2021Loss of or Failure to Bond; Material Integrity Problem; Loss of or Failure to Bond; Material Integrity Problem

  THE SPONGE ON THE STICK FROM THE KIT CAME OFF WHEN INSIDE A PATIENT. THEY HAVE TO REMOVE IT FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698577 ↗