FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

EDWARDS DIV., BAXTER HEALTHCARE CORP. SWAN GANZ   back to search results
Catalog Number 43A-931H-7.5F
Event Description

Balloon inflated and visual leakage noted. Withdrawn and new catheter placed at this time.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameSWAN GANZ
Type of DeviceSWAN GANZ
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
EDWARDS DIV., BAXTER HEALTHCARE CORP.
santa ana CA 92711 1150
Device Event Key21687
MDR Report Key21642
Event Key19947
Report NumberMW1005805
Device Sequence Number1
Product CodeDYG
Report Source Voluntary
Report Date 03/21/1995
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/03/1995
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date02/01/1997
Device Catalogue Number43A-931H-7.5F
Device LOT Number5A0006-SC4M1062
OTHER Device ID Number861358001
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on December 31, 2008

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH