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

Device Problem Break (1069)

Patient Problem Emotional Changes (1831)

Event Date 09/05/2019

Event Type  Injury  

Event Description

Pt became agitated and broke bilateral medical soft wrist restraints.Fda safety report id# (b)(4).

• Brand Name: DEROYAL INDUSTRIES MEDICAL SOFT RESTRAINED
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC. ; powell TN 37849
• MDR Report Key: 9069925
• MDR Text Key: 158827369
• Report Number: MW5089792
• Device Sequence Number: 2
• 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: 09/11/2019
• 2 Devices were Involved in the Event: 1 2

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 113