In this article
Put immediate safety firstGather useful identifying detailsUse the official TGA routeUnderstand what a report can and cannot doExample: putting the information in contextWhat to check nextFrequently asked questionsCan patients submit reports directly?Should I include private medical details publicly?Read more on this topicOfficial sourcesRelated articles
Australians can report suspected medical-device problems to the Therapeutic Goods Administration. Clear, factual reports give regulators and suppliers better information to investigate an unexpected failure or injury.
Put immediate safety first
If a device appears to be overheating, damaged or causing harm, stop using it and follow appropriate emergency or clinical guidance. A reporting form should not delay urgent care. If an issue involves a battery, handle it according to official safety advice rather than attempting to repair it at home.
Gather useful identifying details
Find the exact brand, model, relevant serial or batch identifier, supplier details and dates. Describe what happened without speculation. Photographs of packaging, error screens and damaged external parts can help, but do not dismantle a suspect device solely for the report.
Use the official TGA route
The TGA provides reporting guidance for consumers, health professionals and industry. The submission process asks for information about the device and incident. A pharmacist, doctor or supplier may also have reporting responsibilities.
Understand what a report can and cannot do
Submitting information contributes to post-market surveillance. It does not guarantee a recall, compensation or an immediate individual answer. Device complaints, consumer remedies and regulatory incident reports are related but different processes.
Example: putting the information in context
A patient’s device repeatedly shuts down and releases a strong burning smell. After ceasing use and ensuring immediate safety, the patient notes the device identifiers, reports the issue through the official channel and contacts the healthcare professional or supplier.
What to check next
- Stop using equipment that may be dangerous and prioritise health.
- Collect device name, model, identifier, dates and a factual incident description.
- Follow the current TGA adverse event reporting process.
Frequently asked questions
Can patients submit reports directly?
Yes. The TGA encourages reports from consumers as well as healthcare professionals.
Should I include private medical details publicly?
No. Use the official secure reporting process for personal information.
Read more on this topic
- Medical Devices & TGA: topic overview
- Medical Device Recalls and Safety Alerts in Australia
- How to Read Medical Device Product Documentation
Official sources
- TGA — Find information about a medical device: report a problem
- TGA — Medical device adverse events: DAEN and interpretation
This educational information is not individual medical advice. It does not establish the regulatory status or suitability of an unidentified device, and must not be read as authorisation to advertise vaping goods to the Australian public.