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Adverse Event Report

BAXTER HEALTHCARE CORP. EDWARDS CVS DIV. EDWARDS PERICARDIAL PATCH   back to search results
Model Number 4700
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

This evnet was reported as ischemic ventricular septal defect and infarction. No further information provided.

 
Manufacturer Narrative

F1: user facility. 2200 = "ischemic ventricular septal defect. H6: 86 = device not returned.

 
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Brand NameEDWARDS PERICARDIAL PATCH
Type of DevicePERICARDIAL PATCH
Baseline Brand NameEDWARDS PERICARDIAL PATCH
Baseline Generic NameNA
Baseline Catalogue NumberNA
Baseline Model Number4700
Baseline Device FamilyPERICARDIAL PATCH
Baseline Device 510(K) NumberK833763
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)48
Date First Marketed11/01/1984
Manufacturer (Section F)
BAXTER HEALTHCARE CORP. EDWARDS CVS DIV.
17221 red hill avenue
irvine CA 92614
Manufacturer (Section D)
BAXTER HEALTHCARE CORP. EDWARDS CVS DIV.
17221 red hill avenue
irvine CA 92614
Manufacturer (Section G)
BAXTER HEALTHCARE CORP.
17221 red hill ave.
irvine CA 92614
Manufacturer Contact
allison mezzanatto
17221 red hill avenue
irvine , CA 92614-5686
(949) 250 -2562
Device Event Key88254
MDR Report Key89272
Event Key83924
Report Number6000002-1997-00389
Device Sequence Number1
Product CodeMFX
Report Source Manufacturer
Source Type Study
Reporter Occupation Physician
Type of Report Initial
Report Date 04/04/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/02/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date09/01/1998
Device MODEL Number4700
Device LOT Number4I1180
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age3 yr
Event Location Hospital
Date Manufacturer Received04/04/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/1994
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Database last updated on February 28, 2009

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