Safety & adverse event reporting

Reporting a problem with your device

If your Elite II device is faulty, behaves unexpectedly, or is associated with an injury or adverse event, we want to know. Reporting helps us monitor device safety and meet our regulatory obligations. You can report to us directly, and you can also report independently to the medical device regulator in your country.

1. Report to Grenco Medical

Contact our support team and tell us what happened. Where possible, include your device serial number, what you were doing when the problem occurred, and any photos.

• Australia & New Zealand: support@moodstatemedical.au · +61 1300 069 385
• North America: support@grencomedical.com · +1 833-691-3224
• Or use our contact form.

2. Report to the medical device regulator

Australia — Therapeutic Goods Administration (TGA)

Consumers and patients in Australia can report a medical device adverse event directly to the TGA:

• Online form: Report a medical device adverse event (medical device user)
• More information: Report an adverse event or safety problem
• TGA reporting support: iris@tga.gov.au · 1800 809 361

New Zealand — Medsafe

Patients and consumers in New Zealand can report a medical device problem to Medsafe, the New Zealand medicines and medical devices safety authority:

• Medsafe: medsafe.govt.nz

What to include in a report

• The device name (Grenco Medical Elite II Vaporiser) and serial number, if available.
• A description of the problem or adverse event and when it happened.
• Any harm or injury that occurred, and any medical attention sought.
• Your contact details, so we can follow up if needed.

Recalls and safety notices

There are no current recalls or safety notices for the Elite II. If a safety notice is ever issued, it will be published on this page and communicated through the relevant channels.