DeRoyal 89-4393Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756585750), received between Mar 18, 2022 and Apr 13, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Packaging 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

Recent adverse event reports

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

• MalfunctionApr 13, 2022No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available

  THE SURGICAL TEAM OPENED A CHRONIC EAR PACK FOR A PROCEDURE. INSIDE WERE 10 4X4 X-RAY DETECTABLE SPONGES WRAPPED IN A PAPER BAND; BUT THERE WAS ALSO A LOOSE 4X4 X-RAY DETECTABLE SPONGE LOOSE IN THE BASIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14101513 ↗
• MalfunctionMar 18, 2022Packaging Problem

  THE SURGICAL TEAM OPENED A CHRONIC EAR PACK FOR A PROCEDURE. INSIDE WERE 10 4X4 X-RAY DETECTABLE SPONGES WRAPPED WITH A PAPER BAND, AS USUAL, BUT THERE WAS ALSO A LOOSE 4X4 X-RAY DETECTABLE SPONGE LOOSE IN THE BASIN.

  Patient problems: Insufficient Information

  MAUDE report 13807805 ↗