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, mechanical - Product Code LWQ
원인
Incorrect product label. the type of sewing ring was mislabeled as being a standard sewing ring instead of an anatomic sewing ring.
조치
On-X LTI Management Team had assessed this event to not be reportable. Correction were done by the On-X LTI in 2015.
Worldwide Distribution - US Nationwide in the states of AL, CA, FL, IA, IN, LA, MA, MN, MO, MS, NC, OR, PA, and TN. and the countries of Finland, United Kingdom and Israel
제품 설명
On-X Prosthetic Heart Valve || Product Usage: || Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions