DeRoyal M8135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756837811), received between May 20, 2024 and Nov 20, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Handling 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.

• MalfunctionNov 20, 2024Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  PATIENT WAS BEING PLACED IN RESTRAINTS FOR SELF-INJURIOUS BEHAVIOR. PATIENT WAS COMBATIVE AND PULLING AT THE RESTRAINT WHILE STAFF WAS ATTEMPTING TO APPLY. A PIECE OF THE RESTRAINT BROKE OFF. THE PLASTIC PIECE BROKE AS A RESULT OF PATIENT AGGRESSION. PER NURSING LEADERSHIP REVIEW, THE RESTRAINTS WERE APPLIED CORRECTLY AND ADDITIONAL RESTRAIN EDUCATION IS BEING PROVIDED. THE TRIANGLES ON THE NORIX PLATFORM BED WERE NOT BEING UTILIZED DURING THE ABOVE EVENT.

  Patient problems: Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 20734118 ↗
• MalfunctionMay 20, 2024Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  CLINICAL 4-POINT RESTRAINTS WERE APPLIED BY SECURITY OFFICER AND REGISTERED NURSE AS POLICE CAREFULLY REMOVED THE POLICE WRAP. AFTER RESTRAINTS WERE APPLIED, EMERGENCY ROOM REGISTERED NURSE WAS WAITING FOR MEDICATION TO BE ORDERED TO CALM PATIENT, AS PATIENT WAS CONTINUOUSLY PHYSICALLY AGGRESSIVE WHILE RESTRAINED AND YELLING AT POLICE OFFICERS IN EMERGENCY ROOM 4. WHILE WAITING FOR MEDICATION, PATIENT WAS ABLE TO BREAK THE RIGHT WRIST RESTRAINT IN HALF CAUSING POLICE OFFICERS TO REACT AND GRAB PATIENT'S RIGHT ARM AND APPLY HAND CUFFS TO BOTH LEFT AND RIGHT WRIST. SHORTLY AFTER PATIENT WAS CUFFED TO BED BY POLICE, MEDICATION ORDER CAME IN AND SECURITY OFFICER ENTERED EMERGENCY ROOM 4 TO ASSIST EMERGENCY ROOM REGISTERED NURSE WHILE GIVING THE MEDICATION. SECURITY THEN CLEARED AND POLICE SAT AND WATCHED PATIENT, WHO LATER WAS MEDICALLY CLEARED AND WAS DISCHARGED WITH POLICE. PATIENT'S URINE DRUG SCREEN WAS POSITIVE FOR ILLEGAL SUBSTANCES.

  Patient problems: Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 19350830 ↗