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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP SORIN 3T HEATER COOLER

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SORIN GROUP SORIN 3T HEATER COOLER Back to Search Results
Catalog Number 16-02-82
Device Problem Insufficient Information (3190)
Patient Problems Purulent Discharge (1812); Pain (1994)
Event Date 03/25/2015
Event Type  Injury  
Event Description

Patient had septal myomectomy and mitral valve replacement on (b)(6) 2015 and had the sorin heater cooler 3tm used then developed a mass at the lower end of her sternum (b)(6) 2016. Continued to have pain and pus started to come out of wound.

 
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Brand NameSORIN 3T HEATER COOLER
Type of DeviceSORIN 3T HEATER COOLER
Manufacturer (Section D)
SORIN GROUP
muchen 80939 DE
MDR Report Key6519166
MDR Text Key73729577
Report NumberMW5069277
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
Type of Report Initial
Report Date 04/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
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?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/21/2017 Patient Sequence Number: 1
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