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30 Cochlear Aqua+ User Guide
Serious incidents
Whilst serious incidents in relation to medical devices are rare, it
is acknowledged that incidents may happen. As an organisation,
Cochlear recognises the potential for harm and will respond to
any reported serious incident.
What is a serious incident?
A ‘serious incident’ means any event that directly or indirectly
has caused or could have caused an unexpected or unwanted
event including any of the following:
ꞏ The death of a patient, user or other person,
ꞏ The temporary or permanent serious deterioration of a
patient’s, user’s or other person’s state of health,
ꞏ A serious public health threat.
Reporting a serious incident
There is no denitive list of events/incidents that constitute a
serious incident, however all serious incidents should be
reported to:
ꞏ Your local Cochlear oce
www.cochlear.com/intl/contact/global-oces
People within the European Union should also report all serious
incidents to:
ꞏ Your National Competent Authority
http://ec.europa.eu/growth/sectors/medical-devices/
contacts_en
People within Australia should also report all serious incidents
to:
ꞏ Therapeutic Goods Administration
https://www.tga.gov.au
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