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
Biliary catheter - Product Code FGE
원인
A protege ps biliary stent system was mislabeled. the mislabeling resulted in a 9 mm diameter, 60 mm length stent being labeled as a 6 mm x 60 mm stent.
조치
The single affected consignee was visited by an ev3 representative to verify the use of the device or exchange it for an unaffected device. Information recorded on an ev3 Device Reconciliation Form.
Ev3 Protege GPS Biliary Stent Systems || 6 mm, 60 mm, 120cm, .35, 6Fr, OTW || Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 || REF SERB65-06-60-120 || Lot 2675311 || Use before 2009-01-01 || Sterile EO || Intended as a palliative treatment of malignant neoplasms in the biliary tree.