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The Australian and New Zealand Medical Device Incident Report Investigation Scheme
What is it? The Scheme is a joint venture between the Australian Therapeutic Goods Administration and Medsafe, the New
Zealand Medicines and Medical Devices Safety Authority, intended to help maintain the standard of devices used in health
care through voluntary co-operation between users, government and industry. It should be used in conjunction with local
reporting channels. It provides an additional means by which unsafe products or procedures can be identified quickly so
that appropriate action is taken.
Use this form to report any suspected problems with a therapeutic device which has or may present a health hazard.
Reports originating in Australia should be sent to the Therapeutic Goods Administration and reports originating in New
Zealand should be sent to the Ministry of Health.
What should be reported? Typical problems include deficiencies in labelling, instructions or packaging, defective
components, performance failures, poor construction or design. Suggestions for rectifying the problem or improving product
performance would be appreciated.
What happens to your report? The report will be investigated and discussed with the manufacturer/supplier. You may be
contacted for further information. If appropriate both Agencies will assess the issue and it may also be reported to other
Health Authorities. If action is considered necessary it may involve any of the following: 1. Recall - removal of goods from
sale or use, or their correction, for reasons relating to safety, efficiency or quality. 2. Therapeutic Device Alert - urgent
information to inform those responsible for the device, or affected by the problem. 3. Report in a Therapeutic Device
Bulletin (a communication produced by the TGA and distributed in Australia and New Zealand to convey information on
medical devices) or other appropriate journal(s).
Medical Device Incident Report
Use this form to report any suspected problem with a therapeutic device which may create a health hazard. A therapeutic
device is any material instrument, apparatus, machine implement, contrivance, implant etc including any component,
part or accessory which is used in health care and includes diagnostic reagents
A. Product Identification
(Provide all available details. Where * appears, delete whichever is not applicable)
1. Product
Type/Application
(eg Urinary Catheter)
2. Brand/Trade * Name
and Model Number
3. Serial/Batch/Lot *
Number
4.
Date of
manufacture
Date of
purchase
Date of
expiry
* AUSTL or
AUSTR No.
5. Manufacturer’s name
address and telephone
6. Supplier’s name address
and telephone
7. Has the manufacturer been informed of the problem? Yes
o
No
o
If Yes, please supply the date and contact name
8. Is the product/packaging * available for inspection? Yes
o
No
o
(please do not discard these items)
Important: Please fill in Sections B and C overleaf