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TF 200.11.0006_eng
11. Accident reporting
The manufacturer of this product recommends any accident with this product that meets all the following
criteria reported to the appropriate authority as well as to the manufacturer.
1. There has been or could have been an accident
2. The medical device is considered to be a contributing factor to the case, and
3. The event resulted or could have resulted in one of the following outcomes:
•
Death - a patient, a user or a third party’s death
•
A serious deterioration of a patient's health, a user's health or a third party's health status in
the form of:
o
a. Life-threatening disease
o
b. Lasting damage or injury
o
c. Necessary medical or surgical treatment to divert life-threatening illness,
permanent injury
o
d. Fetal death, fetal injury, or congenital abnormalities
