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
Shunt, central nervous system and components - Product Code JXG
원인
Some miethke shunt system accessories may have an incorrect mr safety symbol on the shelf box label. the label should have no symbol but instead is marked with the mr conditional symbol. the product is mr unsafe. this information is only required to be in the instructions for use (ifu).
조치
Aesculap sent an Important Correction and Removal and Field Safety Notification letter, dated December 17, 2014, to all affected customers. The letter identiifed the affected product, problem, and actions to be taken. Customers were requested to remove from inventory and contact Aesculap regarding return of the affected devices and acknowledgement form.
Miethke Shunt System accessories || Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.