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Adverse Event Report

BAXTER HEALTHCARE CORP. EDWARDS CVS DIV. CARPENTIER EDWARDS BIOPROSTHESIS REPLACEMENT HEART VALVE   back to search results
Model Number 2625
Event Date 11/20/1996
Event Type  Injury   Patient Outcome  Required Intervention;
Manufacturer Narrative

F1: user facility. H6: 86=none.

 
Event Description

This event was reported as recurrent stenosis. No further info provided.

 
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Brand NameCARPENTIER EDWARDS BIOPROSTHESIS
Type of DeviceREPLACEMENT HEART VALVE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BAXTER HEALTHCARE CORP. EDWARDS CVS DIV.
17221 red hill ave
irvine CA 92614
Manufacturer (Section D)
BAXTER HEALTHCARE CORP. EDWARDS CVS DIV.
17221 red hill ave
irvine CA 92614
Manufacturer (Section G)
BAXTER HEALTHCARE CORP.
17221 red hill ave.
irvine CA 92614
Device Event Key63807
MDR Report Key63641
Event Key59796
Report Number6000002-1997-00054
Device Sequence Number1
Product CodeLWR
Report Source Manufacturer
Source Type Study
Reporter Occupation Physician
Type of Report Initial
Report Date 12/18/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/17/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date06/01/1987
Device MODEL Number2625
Device LOT Number3E565
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age13 yr
Event Location Hospital
Date Manufacturer Received12/18/1996
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/1983
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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