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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-19 for * manufactured by *.

Event Text Entries

[441314] An extremely agitated pt was admitted through the ed in 4 point leather restraints he was being transferred from the ed stretcher onto the inpt bed when he was arrested. They were in the process of reapplying the restraints when he coded. The pa dept of health and cms have both been notified the doh conducted an investigation. The coroner did an autopsy & the cause of death was arterioscleretre cardio - vascular disease.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 705600
• MDR Report Key: 705600
• Date Received: 2006-04-19
• Date of Report: 2006-04-19
• Date of Event: 2005-10-21
• Date Facility Aware: 2005-10-24
• Report Date: 2006-04-19
• Date Reported to FDA: 2006-04-20
• Date Added to Maude: 2006-05-02
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: LEATHER RESTRAINTS
• Product Code: BRT
• Date Received: 2006-04-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 694670
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2006-04-19