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Adverse Event Report

COOK MANUFACTURING VITA PORT VASCULAR ACCESS DUAL PORT   back to search results
Model Number IPS-1125
Device Problem Device failure
Event Date 03/09/1999
Patient Outcome  Hospitalization;
Event Description

Vascular access port malfunction, took out port & reinserted new one.

 
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Brand NameVITA PORT
Type of DeviceVASCULAR ACCESS DUAL PORT
Baseline Brand NameVITA PORT
Baseline Generic NameVASCULAR ACCESS DUAL PORT
Baseline Model NumberIPS-1125
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
COOK MANUFACTURING
1100w. morgan st
p.o. box 227
spencer IN 47460
Device Event Key212650
MDR Report Key219272
Event Key205727
Report Number219272
Device Sequence Number1
Product CodeLJT
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/12/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/14/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberIPS-1125
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/09/1999
Device Age3 mo
Event Location Hospital
Date Report TO Manufacturer03/12/1999
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on January 30, 2009

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