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Medical Devices

Revised: 20 December 2014

Adverse Event Reporting

Reporting Adverse Events Associated With Medical Devices

This information will help you understand more about the reporting of adverse events associated with medical devices. If you have any concerns about a medical device, Medsafe encourages you to talk to your doctor, pharmacist, nurse or other health professional. Medsafe cannot give advice about an individual's medical condition or treatment.

Why report a suspected adverse event?

An adverse event is an unexpected consequence associated with the use of a medical device or with an implanted medical device. 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.

Some of these events may be known to be associated with the device and may have been advised to you at the time of use.

You do not have to be certain that the medical device caused the adverse event, just suspicious. It may be difficult to determine if a particular medical device has caused the effect in an individual case. When we receive a number of reports with similar events it helps us to determine if the medical device plays a role in the adverse event.

What happens to the reports?

An acknowledgement of receipt of your report will be sent to you.

Details from each report are entered into a secure database of all reported adverse events. The information in this database is regularly analysed by Medsafe staff to identify possible trends associated with a particular device or group of devices.

If a trend is identified, evaluation and analysis to investigate the relationship between the device and the adverse event may be carried out.

Medsafe may publish some information given on the reporting form, such as the name of the medical device, type of adverse event. However, the published data will NOT include names or other identifiable details of the person who made the report or who the report was about.

What action can Medsafe take?

Medsafe can take a number of actions in response to a safety concern, including:

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.

How do I report possible adverse events?

If at all possible please keep the device and its associated packaging as this may be required to be returned for further investigation.

Medsafe is in the process of redesigning the reporting forms. A new reporting form has been developed for consumers. This is a word document which can be saved onto your computer and completed. Once completed it can be emailed to the address below, or printed and posted to the address below.

A new reporting form for healthcare professionals has also been developed. The reporting form for the medical device industry is due for review in the first quarter of 2017.

Adverse Event Report (Consumers) (Microsoft Word document 85 KB, 3 pages)
Adverse Event Report (Healthcare Professionals) (Microsoft Word document 79 KB, 3 pages)

Email devices@moh.govt.nz
Postal Mail Compliance Management Branch
Medsafe, Ministry of Health
PO Box 5013
Wellington, 6140

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 either of the following ways.

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

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.

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.

Investigation of Reports

All adverse events are reviewed by Medsafe with both safety and quality issues being considered. As part of these reviews 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 request the supplier to provide 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.

What is Medsafe?

Medsafe is the New Zealand Medicines and Medical Devices Safety Authority, part of the Ministry of Health. Medsafe monitors the safety of medicines and medical devices in New Zealand and takes action to ensure any risks of harm are minimised to protect the public.

You can find more information on the work we do at: www.medsafe.govt.nz

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