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Adverse Event Report

DE ROYAL PATIENT CARE DE ROYAL SLEEVED VEST RESTRAINT   back to search results
Model Number M2382
Device Problem Installation error
Event Date 01/21/1999
Patient Outcome  Death;
Event Description

This event was not recognized as a potential reportable safe medical/mdr event. The patient was found on the floor in his posey restraint. The vest was not around his neck, but was still attached to his body. Facility speculates the patient's body weight, pulling on the straps attached to his vest caused him to express air out of his lungs causing respiratory failure.

 
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Brand NameDE ROYAL
Type of DeviceSLEEVED VEST RESTRAINT
Baseline Brand NameDE ROYAL
Baseline Generic NameSLEEVED VEST RESTRAINT
Baseline Model NumberM2382
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DE ROYAL PATIENT CARE
200 de busk lane
powell TN 37849
Manufacturer (Section D)
DE ROYAL PATIENT CARE
200 de busk lane
powell TN 37849
Device Event Key204407
MDR Report Key210646
Event Key197646
Report Number210646
Device Sequence Number1
Product CodeFMQ
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/09/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/09/1999
Is This An Adverse Event Report? No
Device Operator Other
Device MODEL NumberM2382
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/09/1999
Distributor Facility Aware Date02/04/1999
Event Location Hospital
Date Report TO Manufacturer02/09/1999
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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