*

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 Number705600
MDR Report Key705600
Date Received2006-04-19
Date of Report2006-04-19
Date of Event2005-10-21
Date Facility Aware2005-10-24
Report Date2006-04-19
Date Reported to FDA2006-04-20
Date Added to Maude2006-05-02
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameLEATHER RESTRAINTS
Product CodeBRT
Date Received2006-04-19
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Device AgeUNKNOWN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key694670
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2006-04-19

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