MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. RESTRAINT; RESTRAINT, PROTECTIVE

Patient Problem Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 04/07/2024

Event Type  malfunction  

Event Description

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.Www.Deroyal.Com, phone#: 888-938-7828.Universal.

• Brand Name: RESTRAINT
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk ln.; powell TN 37849
• MDR Report Key: 19078770
• MDR Text Key: 339944869
• Report Number: MW5153677
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White