This webpage provides medical devices risk information which has come under review by the PMDA and MHLW. Information provided here is as follows:
Risk information for which the PMDA and MHLW have started their evaluation
Risk information for which the PMDA and MHLW have started their evaluation based on studies published in scientific journals, etc.
[To Patients]
Information provided here is still under review.
| Date | Nonproprietary Name | Risk Information of Ongoing Evaluation | Related Information | Investigation Results |
|---|---|---|---|---|
| July 23, 2025 | Cadaveric dura mater note) | Summary of Investigation [273 KB] Response to the reported cases of “cerebral amyloid angiopathy” in patients with a history of cadaveric dura mater graft Appendix 1 [230 KB] Individual Case List |
(References) Material for the 2025 Committee on Safety of Medical Devices and Regenerative Medical Products in the Pharmaceutical Affairs Council (the 1st meeting) (only in Japanese) |
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