Information for Medical Device Suppliers
Medical Device Adverse Event Reporting
Adverse events that cause injury and that are associated with medical devices should be reported to Medsafe. Such events may be indicative of a quality or safety issue that needs to be addressed in some form. By reporting these to Medsafe seemingly isolated incidents may be collated and responded to.
Definition of a reportable event
Non-reportable events
Who can report an adverse event?
Reporting Timelines
Adverse Event Reporting form (Sponsors & Manufacturers)
Adverse Event Reporting form (Healthcare Professionals, patients)
Investigation of Reports
Definition of a reportable event
For an event to be considered reportable to Medsafe it should meet all of the following criteria.
- An event must have occurred. Typical events are;
- A malfunction or deterioration in the characteristics or performance
- An incorrect or out of specification result
- An inaccuracy in the labelling, instructions for use and/or in promotional materials. Inaccuracies include omissions and deficiencies.
- The discovery of a serious public health threat
- Use error
- An identified medical device is associated with the event.
- The event led to one of the following outcomes;
- The death of a patient, user, or other person
- Serious injury to a patient, user, or other person. Serious injury being a life threatening illness or injury; permanent impairment of a body function or permanent damage to a body structure; a condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.
- No death or serious injury occurred but the event might lead to death or serious injury of a patient, user, or other person if the event recurs.
Non-Reportable Events
The following events are not considered to be reportable events and need not be reported to Medsafe.
- Deficiency of a new device found by the user prior to its use. Deficiencies of devices that would always be detected by the user and where no serious injury has occurred are not reportable events.
- Adverse event caused by patient conditions. Where the root cause of the event is due to a patient condition, the event is not reportable.
- Service life or shelf life of the medical device. When the only cause for the adverse event was that the device exceeded its service life or shelf life as specified by the manufacturer and the failure mode is not unusual.
- Malfunction protection operated correctly. Adverse events which did not lead to serious injury or death, because a design feature protected against a malfunction becoming a hazard is not a reportable event.
- Expected and foreseeable side effects.
- Adverse events described in a recall, corrective action, alert, or field safety notice.
Who can report an Adverse Event?
Anyone can submit an adverse event report. Patients, caregivers, healthcare professionals and suppliers are all encouraged to lodge an adverse event report if an incident has occurred and there is a concern about the safety of the device or its use.
Reporting Timelines
It is important that adverse event reports are submitted to Medsafe promptly after the event. Medsafe recommends that initial reports are filed within the timeframes below;
- Death (actual or potential) - within 7 calendar days
- Serious Injury (actual or potential) - within 7 calendar days
- Injury (actual or potential) - within 30 calendar days
- No injury - within 30 calendar days
Adverse Event Reporting form (Sponsors & Manufacturers)
Medsafe recommends that sponsors and manufacturers use the TGA MDIR03 form when lodging adverse event reports with Medsafe. When using this form please replace the ARTG number with the WAND number for the device.
Completed adverse event report forms may be submitted to Medsafe by any of the following ways;
- Fax to 04-819-6800
- Email to devices@moh.govt.nz
- Post to the Compliance Management Branch, Medsafe, PO Box 5013, Wellington, 6415.
Download the TGA MDIR03 reporting form (Microsoft Word Document 153 KB)
Adverse Event Reporting form (Healthcare Professionals, patients)
Healthcare professionals, patients, and carers lodging adverse event reports with Medsafe should use the joint Medsafe-TGA adverse event reporting form.
Completed adverse event report forms may be submitted to Medsafe by any of the following ways;
- Fax to 04-819-6800
- Email to devices@moh.govt.nz
- Post to the Compliance Management Branch, Medsafe, PO Box 5013, Wellington, 6415.
Download the Medsafe-TGA adverse event reporting form (Microsoft Word document 139 KB)
Investigation of Reports
All adverse events are reviewed by Medsafe with both safety and quality issues being investigated. As part of these investigations further information may be requested from the reporter and/or the device supplier. If necessary, Medsafe may also contact overseas regulatory agencies to ascertain whether they have received reports about the device.
In response to an adverse event, or series of adverse events, Medsafe may issue an advice or alert. If a product issue is found then Medsafe will work with the supplier on an appropriate corrective action to address the issue. The Medical Device Incident Review Committee (MDIRC) reviews all adverse events reported in New Zealand and Australia to ensure they have been appropriately responded to. MDIRC is an independent group of healthcare professionals nominated by the various professional bodies and colleges. MDIRC may also recommend further action to be taken. The MDIRC committee meets 4 times a year to review adverse event reports.
All reports received are retained by Medsafe.
Page last updated 10 May 2011