| All fields marked with a * are mandatory fields |
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| Report Details |
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Report Type: |
Date of Report: |
TGA Report Number: |
TGA Form ID: |
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Date of Adverse Event: |
Date Manufacturer Aware: |
Report Category: |
Reporter's Reference Number: |
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| Reporter Details |
A report without contact details cannot be processed. |
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Title: *
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First Name: *
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Surname of Contact: *
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Company / Institution: *
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| Position / Occupation: *
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Address Line 1: *
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| Phone: *
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Fax: |
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Address Line 2: |
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| Email: |
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Country: |
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Town / Suburb: *
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State / Province: *
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Postcode: *
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| Healthcare Facility Details |
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Title: |
First Name: |
Surname of Contact: |
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Company / Institution: |
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| Position / Occupation: |
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Address Line 1: |
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| Phone: |
Fax: |
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Address Line 2: |
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| Email: |
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Town / Suburb: |
State: |
Postcode: |
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| Device Identification |
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Device ARTG Number: |
GMDN Code: |
GMDN Text: |
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| Brand / Trade Name: *
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Software Version (If Relevant): |
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| Device Model: |
Serial Number: |
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If the device is an implantable device, indicate the implant date and if relevant the explant date below: |
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| Batch Number: |
Lot Number: |
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Date of Implant: |
Date of Explant: |
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| Operator at Time of Event: |
Usage of Device: |
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Current Device Location: |
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| Manufacturer's Details |
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| Title: |
First Name: |
Surname of Contact: |
Company Name: *
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| Phone: |
Fax: |
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Address Line 1: |
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| Email: |
Address Line 2: |
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| Manufacturer Client ID: |
Country: |
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Town / Suburb: |
State / Province: |
Postcode: |
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| Clinical Event Information |
Please DO NOT include the names of hospitals or persons involved in the event.
Use the section above 'Healthcare Facility Details' for this information. |
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Description of Event or Problem: *
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| Patient Information |
Please provide information if relevant. eg. weight of patient in regards to orthopaedic implants. |
| Sex: |
Age (Years, Months): |
Weight (Kg): |
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| Corrective Action Taken Relevant to Care of Patient: |
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| Patient History (Co-morbidities & Medication): |
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| Patient Outcome / Consequences: |
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| Other Devices Involved in Event: |
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| Results of Manufacturer's Investigation |
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Manufacturer's Device Analysis Results: |
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| Remedial Action / Corrective Action / Preventative Action: |
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| Other Reporting Information |
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Other Similar Events Manufacturer / Sponsor Aware of: |
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| Countries Where These Similar Adverse Events Occurred: |
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| Additional Comments: |
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| Report Attachments |
Please attach any additional documation or information such as pictures if necessary and / or available.
Attachments can be any type of Office file, PDF or ZIP file.
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Select additional file and press Add button to attach to report (up to 3MB each). Repeat for multiple files (up to 16MB in total): |
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| Submit Report To TGA |
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Once you have provided all available details within the report submit the report directly to the TGA. |
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