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Medical Devices

Revised: 21 November 2014

Adverse Event Reporting

Adverse events occurring in New Zealand 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.

Summary Information from these reports will be published in the Joint Adverse Events Notification System (JAENS-MD).

Joint Adverse Events Notification System (JAENS-MD)

Definition of a Reportable Event

For an event to be considered reportable to Medsafe it should meet all of the following criteria.

  1. 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
  2. An identified medical device is associated with the event.
  3. 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.

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 Timetables

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.

Adverse Event Reporting Form (Sponsors and 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.

TGA MDIR03 medical device reporting form (Word 137 KB, 3 pages)

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.

Medsafe-TGA medical device adverse event reporting form (Word 104 KB, 3 pages)

Investigation of Reports

All adverse events are reviewed by Medsafe with both safety and quality issues being considered. As part of these ireviews 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 similar 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 Advisory Committee on the Safety of Medical Devices (ACSMD) reviews all adverse events reported in New Zealand and Australia to ensure they have been appropriately responded to. ACSMD is an independent group of healthcare professionals nominated by the various professional bodies and colleges. ACSMD may also recommend further action to be taken. The ACSMD committee meets 4 times a year to review adverse event reports.

All reports received are retained by Medsafe.

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