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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN SORIN HT3 HCD STOCKER TEMPERATURE CONTROLLER

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SORIN SORIN HT3 HCD STOCKER TEMPERATURE CONTROLLER Back to Search Results
Catalog Number 16-02-82
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 06/04/2012
Event Type  Injury  
Event Description

Patient underwent resection of ascending aortic aneurysm with graft placement.

 
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Brand NameSORIN HT3 HCD STOCKER
Type of DeviceTEMPERATURE CONTROLLER
Manufacturer (Section D)
SORIN
MDR Report Key5986532
MDR Text Key56095525
Report NumberMW5065079
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/27/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number16-02-82
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/27/2016 Patient Sequence Number: 1
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