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Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Instrument 2023
Part 1DAEN — Medical Devices
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Part 1—DAEN – Medical Devices
| Column 1 | Column 2 |
|---|---|
| Item | Kinds of therapeutic goods information |
| 1 | information about an adverse event or defect in relation to a medical device or other therapeutic good, that has been reported to the TGA and is recorded in the DAEN – Medical Devices (medical device adverse event report), as follows:(a) details of the medical device or other therapeutic good;(b) details of the manufacturer of the medical device or other therapeutic good;(c) details of the sponsor of the medical device or other therapeutic good;(d) details of any other therapeutic good reported to have been involved in the adverse event;(e) the description of the adverse event;(f) the event outcome;(g) the event type;(h) the report source category;(i) the date that the medical device adverse event report was received by the TGA;(j) the unique number allocated to the medical device adverse event report by the TGA |