PMDA Alert for Proper Use of Medical Devices

“PMDA Alert for Proper Use of Medical Devices” aims to provide information to healthcare professionals in an easy-to-understand manner. The information presented here includes, among medical device malfunction/infection cases reported, such cases where the reporting frequencies of similar cases have not decreased in spite of the fact that precautions for those medical devices have been already issued in package inserts or in other ways.
 

No.	Posted in	Title
3	March 2022	Bleeding Caused by the Use of IMPELLA Circulatory Assistance Pump Catheter [282 KB]
2	July 2018	Adverse Events involving the Use of Bioprostheses for Transcatheter Aortic Valve Implantation [103 KB]
1	July 2017	Adverse Events Associated with the Use of Aortic Stent-Grafts [125 KB]

 

Considerations for using "PMDA Alert for Proper Use of Medical Devices"

Any actions related to reproduction, reprint, distribution, etc. without our permission are prohibited regarding the PMDA Alert for Proper Use of Medical Devices except for the following cases.

• Use in your own medical institutions, pharmacies, academic societies, or healthcare-related organizations, etc.
• Use by the marketing authorization holders of medical devices or drugs related to “PMDA Alert for Proper Use of Medical Devices”