Adverse event reporting
What is an adverse event?
An adverse event involving a medical device is an incident where:
- A device has malfunctioned, failed, or deteriorated
- The malfunction or failure caused or could have caused serious injury or death to a patient, user, or other person
The obligation to report applies when the event is serious — near-misses and incidents that caused no harm but revealed a latent risk should also be evaluated for reportability.
Who must report?
The New Zealand Sponsor is responsible for reporting adverse events to Medsafe. Healthcare providers (hospitals, clinics, practitioners) are encouraged to report directly to Medsafe as well, but the formal regulatory obligation sits with the Sponsor.
Manufacturers located overseas should have processes to ensure that:
- Adverse events reported to them that involve NZ-supplied devices are forwarded to the NZ Sponsor
- The Sponsor has all the information needed to report to Medsafe
What must be reported
Report to Medsafe when a device:
- Malfunctioned or failed in a way that led to serious injury or death
- Could have led to serious injury or death if the circumstances had been slightly different
- Was the subject of a field safety corrective action (recall or correction) by the manufacturer anywhere in the world, which also affects devices supplied in NZ
Reporting timeframes
| Situation | Timeframe |
|---|---|
| Serious injury or death that occurred | 10 working days from becoming aware |
| Potential serious injury or death (near-miss) | 10 working days from becoming aware |
| International FSCA affecting NZ-supplied devices | As soon as practicable |
These are general guidelines from Medsafe guidance. For urgent situations involving immediate risk, contact Medsafe by phone without delay.
How to report
Reports are submitted via Medsafe's adverse event reporting process:
- Email: devices@health.govt.nz
- Medsafe may also have a web form — check medsafe.govt.nz for the current submission method
A report should include:
- Device details (name, model, GMDN, WAND reference if available)
- Description of the event
- Date of the event and date Sponsor became aware
- Patient/user outcome
- Any corrective action taken or planned
Exemptions from reporting
Not all device-related incidents need to be reported. Events that are:
- Expected side effects that are listed in the device labelling/IFU and are not more severe than expected
- Events caused entirely by patient condition rather than device failure
- Events where the device performed as intended but the outcome was poor due to clinical factors
These should still be recorded internally as part of post-market surveillance, even if not reported to Medsafe.
Healthcare provider and patient reports
Healthcare providers and patients can also report adverse events directly to Medsafe. Medsafe uses this information alongside Sponsor reports to identify safety signals. Sponsors should encourage their customers (hospitals, clinics) to report, and should have processes to receive and act on reports coming from end users.