All the information in the database loads when you land on the search page. You can refine the results by date, product name and advanced search options and by interacting with the graphs and tables.
You can choose to display your results either as tables and graphs or as graphs only. Switching between these two views will reset the search filters.
You can also export your search results by interacting with the tables.
Once you have typed the first three characters from a trade name, sponsor, manufacturer, Global Medical Device Nomenclature (GMDN) term (device descriptor e.g. 'hip', 'pump' etc.), or an ARTG number, a list of options will be displayed showing, in order, manufacturer, trade name and the GMDN term shown in brackets.
Select the medical device/s you want to search for by ticking or unticking the boxes.
More information on medical device searches
Searches on trade names, sponsor, manufacturer, GMDN terms, and ARTG numbers will produce different results in most cases.
- Trade name and ARTG number searches are more suitable for conducting specific medical device searches. If you are unsure of the exact spelling of the trade name, you can enter the first few letters and search through the results.
- Sponsor searches and manufacturer searches can be used for conducting more general searches particularly where you are unsure of the trade name of a medical device.
- GMDN term searches are most suited to conducting searches on types of medical devices (for example 'hip', 'pump') which may be manufactured and/or sponsored by different companies.
- The selection of medical devices is limited to those contained within the Database of Adverse Event Notifications - medical devices.
- For searches using trade name, sponsor name, manufacturer name, GMDN term or ARTG number the list of displayed options will be filtered further as you enter additional characters.
Date range
To change the date range:
- move the slider buttons under the date fields
- click on the from/to date fields and select dates from the calendar
- type your dates in the date field – highlight the numbers in the from/to date field, delete and type in dates in dd/mm/yyyy format.
The report date does not necessarily reflect the date of the adverse event. Although reports are often received soon after an adverse event has occurred, there are occasions, often in response to the publicising of a particular adverse event, that the TGA continues to receive reports of adverse events many years after they occurred.
Product name
To display search results for a specific medicine, vaccine or biological:
- type the product's trade name or active ingredient, then press enter to run the search
- select individual products from the scrollable list (The counter will indicate how many products have been selected.)
- click on the Reset button to clear the search terms.
Searching by active ingredient will usually give the most comprehensive results, particularly for products marketed under multiple trade names. If the person who reported the adverse event has only provided the active ingredient, the database will display 'Trade name not specified' followed by the name of the active ingredient in brackets.
Searches using the trade name can be useful when looking up biological medicines, vaccines and complementary medicines, which often have long names or many active ingredients.
Summary and list of reports tables
There are two types of search results.
- Summary
The summary provides general details of the reported medicine or medical device/s involved. - List of reports
The list of reports details contains further information on the reported medicine or medical device/s involved and a description of the adverse event for each report (de-identified).
Summary table
For medicines
| Heading | Description |
|---|---|
| MedDRA system organ class | A description of the type of adverse event classified mostly according to a specific part of the body in the Medical Dictionary for Regulatory Activities (MedDRA). (for example, atrial fibrillation would come under 'Cardiac disorders'). |
| MedDRA reaction term | A description of the adverse event as defined by (MedDRA. These adverse events are grouped by system organ class. |
| Number of cases | The number of cases in which the adverse event was listed. |
| Cases with a single suspected medicine | Results show when a medicine, vaccine or biological is the only product suspected to be related to the adverse event. |
| Cases where death was a reported outcome | These reports of death may or may not have been the result of taking a product. |
For medical devices
| Heading | Description |
|---|---|
| Report number | A unique number that provides a reference to a particular report. |
| Report date | The date that TGA received the finalised report. This date does not necessarily reflect the date of the adverse event. Although reports are often received soon after an adverse event has occurred, there are occasions, often in response to the publicising of a particular adverse event, that the TGA continues to receive reports of adverse events many years after they occurred. |
| Trade name | The trade name is the name under which the medical device is sold. This is also known as the brand name. |
| Sponsor | The person or company responsible for the supply in and/or exportation from Australia of a therapeutic product. Sponsors must hold an ARTG licence for these products, unless exempted. |
| Manufacturer | The person or company responsible for the design, production, packaging and labelling of a therapeutic product before it is supplied under their name. |
| ARTG number | The entry number on the Australian Register of Therapeutic Goods (ARTG). Therapeutic products must be entered on the ARTG before they can be lawfully supplied in Australia. |
| GMDN term | A description of the medical device as defined by the Global Medical Device Nomenclature system. |
List of reports table
For medicines
| Heading | Description |
|---|---|
| Case number | A unique number that provides a reference to a particular case. |
| Report entry date | This is the date the information from the original report was entered into the database, not the date of the adverse event. Most reports are received soon after an adverse event occurs, but the TGA can receive reports many years after the event occurred. This often happens in response to a particular adverse event being publicised. |
| Medicines reported as being taken | There are three types of links between a product and an adverse event:
The type of link is specified by the person submitting the adverse event report. |
For medical devices
| Heading | Description |
|---|---|
| Report number | A unique number that provides a reference to a particular report |
| Report date | The date that TGA received the finalised report. This date does not necessarily reflect the date of the adverse event. Although reports are often received soon after an adverse event occurred, there are occasions, often in response to the publicising of a particular adverse event, that the TGA continues to receive reports of adverse events many years after they occurred. |
| Trade name | The trade name is the name under which the medical device is sold. This is also known as the brand name. |
| Sponsor | The person or company responsible for the supply in and/or exportation from Australia of a therapeutic product. Sponsors must hold an ARTG licence for these products, unless exempted. |
| Manufacturer | The person or company responsible for the design, production, packaging and labelling of a therapeutic product before it is supplied under their name. |
| ARTG number | The entry number on the Australian Register of Therapeutic Goods (ARTG). Therapeutic products must be entered on the ARTG before they can be lawfully supplied in Australia. |
| GMDN term | A description of the medical device as defined by the Global Medical Device Nomenclature system. |
| Device classification | The medical devices regulatory framework has a classification system for medical devices. The classification is based on the relative risk of the device. For medical devices, see the Australian Regulatory Guidelines for Medical Devices (ARGMD) Part 1 – Section 4 for more information. For IVD medical devices, see Classification of IVD medical devices for more information. |
| Sterile | The manufacturer has indicated the medical device has been designed, produced and packaged in a way that ensures it is sterile when supplied. |
| Single use | The medical device is intended to be used on an individual patient during a single procedure and then discarded. It is not intended to be reprocessed and used on another patient. |
| Model number | The alphanumeric code assigned by the manufacturer to identify a specific product type. The presented identification number may represent a model, catalogue or part number. |
| Software version | The alphanumeric code assigned by the manufacturer to identify a specific release of a program. |
| Event description | A description of the adverse event. |
| Reported event outcome | A description of the outcome reported to have been caused by the adverse event. |
| Report source category | A general category describing the type of person who made the report. |
| Event type | General categories describing the type of adverse event as defined in the ISO/TS 19218-1:2011 - Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes. |
| Other medical devices reported as being used | A list of other medical devices reported to be associated with the adverse event. |
The Database of Adverse Event Notifications - medical devices is updated monthly and the search page reflects the date of the most recent update.
Reports generated on different days may be different, even if the same date range is searched, because the TGA receives follow-up information from reporters that leads to reports being updated in the database.
Interacting with the tables
- Click on the column headings to sort your results
- Hover over the table to view extra options:
- click the funnel icon to show the filters that have been applied
- click the window with arrow icon to view the table in full screen mode.
- click the three-dot icon and select 'Export data' to export your results.
To export data in Microsoft Excel (.xlsx) format select 'Data with current layout'. Up to 150,000 rows can be exported in a single file.
To export in Comma Separated Values (CSV) format, select 'Summarised data'. Up to 30,000 rows can be exported in a single file.
Advanced search options
Use the advanced search options to narrow your search by age, gender and adverse event (MedDRA system organ class or reaction terms).
The MedDRA system organ class is the highest level of the MedDRA terminology. It groups reaction terms by anatomical or physiological system, aetiology (disease origin) or purpose. Most of these describe disorders of a specific part of the body.
To search for a group of related reactions, you can first select a MedDRA system organ class, then select the MedDRA reaction terms.
Advanced search fields are optional and allow you to specify particular ISO event type codes of interest. This will result in a narrower search. You must select a medical device and a date range before you can open the advanced search options.
Only the ISO event type codes recorded for your selected medical device/s and date range will be shown.
There is also an advanced search option where you can restrict your search to particular International Organization for Standardization (ISO) event types.
ISO event type codes
The ISO event type codes are from ISO/TS 19218-1:2011 - Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes. This is the international standard for categorising types of medical device adverse events and assists regulators with sharing information.
The ISO event type codes are:
- Activation, Positioning or Separation
- Computer Hardware
- Computer Software
- Connection or Fitting
- Electrical/Electronic
- External Conditions
- Implantable Device Failure
- Incompatibility
- Infusion/Flow
- Marking, Labelling or Instructions for Use
- Material
- Mechanical
- Non-Mechanical
- Other
- Output Issue
- Packaging/Shipping
- Protective
- Temperature
- Unintended Function
- Use Error
Graphs
To interact with graphs:
- Click on a segment of the pie chart or a bar of the graph to refine the search results.
- Right click on selected data to show more options including full screen view.
- In the ‘Case data by the report date’ graph (Graphs view only), hover over the graph to view extra drill down options, such as viewing the data by year, month and day.
- To undo your selections in the graphs, click on the data again.