In this article
Not every fault is the same as an adverse eventSuspicion is enough to report a concernWhat information makes a report usefulWhat happens to the reportExample: putting the information in contextWhat to check nextFrequently asked questionsDo I need laboratory proof before reporting?Does an entry in DAEN prove the device caused the injury?Read more on this topicOfficial sourcesRelated articles
A medical-device adverse event is a suspected problem involving the device that may have harmed a person or created a serious risk. Reporting concerns helps the TGA identify patterns that may not be obvious from individual experiences.
Not every fault is the same as an adverse event
A loose cosmetic component may be a quality complaint, whereas unexpected overheating, injury or serious malfunction may raise safety concerns. The context, severity and potential consequences matter.
Suspicion is enough to report a concern
A reporter does not need to prove conclusively that a device caused an incident. The TGA’s adverse event information explicitly warns that submitted reports reflect suspected associations, not proven causal findings.
What information makes a report useful
Record the exact device name and model, serial or batch details if available, dates, a factual description of what happened, any injury, accessories used and available photographs. Keep sensitive personal information secure and follow clinical advice when a person may be injured.
What happens to the report
The TGA uses reports as part of safety monitoring and possible investigation. A report is not by itself proof that a device is defective, and the DAEN database should not be used to calculate an individual product’s risk from the count of reports alone.
Example: putting the information in context
A device becomes unusually hot during normal operation and a user receives a burn. The immediate priority is medical assessment and not continuing use. The model, circumstances, photographs and official incident-report channel may then help document the concern.
What to check next
- Describe observable symptoms or malfunction without assuming causation.
- Preserve identifiers, dates and useful photographs safely.
- Report the concern to the TGA and seek urgent care if needed.
Frequently asked questions
Do I need laboratory proof before reporting?
No. Suspected medical-device safety concerns can be reported.
Does an entry in DAEN prove the device caused the injury?
No. The TGA makes clear that reporting does not necessarily establish causation.
Read more on this topic
- Medical Devices & TGA: topic overview
- How Medical Device Problems Are Reported to the TGA
- What Is the Unique Device Identification System?
Official sources
- TGA — Medical device adverse events: DAEN and interpretation
- TGA — Find information about a medical device: report a problem
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.