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Adverse Event Report

DE ROYAL DE ROYAL LIMB RESTRAINT   back to search results
Model Number M 2038
Event Date 09/28/1996
Patient Outcome  Death;
Event Description

Pt found extubated. One limb restraint (wrist) off pt.

 
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Brand NameDE ROYAL
Type of DeviceLIMB RESTRAINT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DE ROYAL
200 de busk lane
powell TN 37849
Manufacturer (Section D)
DE ROYAL
200 de busk lane
powell TN 37849
Device Event Key46023
MDR Report Key45130
Event Key42303
Report Number45130
Device Sequence Number1
Product CodeFMQ
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 10/14/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/22/1996
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberM 2038
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location Hospital
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

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