A FDA C54447 Individual Case Safety Report Terminology C17237 Food and Drug Administration A FDA C54447 Individual Case Safety Report Terminology C53629 Device Evaluated by Manufacturer A FDA C54447 Individual Case Safety Report Terminology C53630 Concomitant Therapy A FDA C54447 Individual Case Safety Report Terminology C54028 EVALUATION METHOD A FDA C54447 Individual Case Safety Report Terminology C54029 EVALUATION RESULT A FDA C54447 Individual Case Safety Report Terminology C54030 EVALUATION CONCLUSION C FDA C54580 Type Of Event ICSR Terminology C41331 ADVERSE EVENT C FDA C54580 Type Of Event ICSR Terminology C53053 TYPE OF EVENT TYPE OF REPORTABLE EVENT C FDA C54580 Type Of Event ICSR Terminology C53054 PRODUCT PROBLEM