DeRoyal M8138Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756946865), received between Oct 14, 2024 and Oct 14, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Feb 27, 2020Terminated

   One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.

   Z-1604-2020 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2024Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  (B)(6) SECURITY TEAM WAS RESTRAINING A VERY COMBATIVE PATIENT (B)(6) 2024 WITH THE DEROYAL M8138 RESTRAINTS. THEY SAID THAT THE PATIENT WAS ABLE TO PULL THEM THROUGH THE BUCKLE AND THEY HAD TO TIE THEM TO THE BED. HE ACTUALLY HOSPITALIZED ONE OF THEIR OFFICERS.

  Patient problems: Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 20439490 ↗