U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Heart Valve, more than minimally manipulated allograft - Product Code DXZ
원인
Staphylococcus aureus (not methicillin resistant) identified in companion tissue.
조치
CryoLife Inc. issued a letter to the physician on February 17, 2011, advising him of the results of the testing performed on a companion cardiac allograft. The letter did not recommend explant of the allograft or special antimicrobial treatment of the patient unless medically necessary.
The physician was asked to complete and return the enclosed, stamped, self-addressed postcard affirming the receipt of the notification.
For any questions the physician was advised to call 770-419-3355.