Tria POSITIVELY CLEAR LUMIERE BLEUE ANTI-ACNE Instructions D'utilisation page 11

POTENTIAL
ADVERSE EVENT
General overuse of
the device, such as
performing many
treatments per day
Use of device on
severe acne
Use of device on or by
children under 13
Use of device on non-
acne skin conditions
Use of device on or
around eyes or eyelids
Use of physically
damaged or wet device
or charger that exposes
user to electrical hazard
Device malfunction with
excessive blue light
output
Continued use
despite side effects
other than warmth,
redness or dryness
that quickly fades
Use of device despite
skin sensitivity to light
Sharing a device
with others who have
common skin bacteria
Sharing a device with
others who have serious
skin infections
LIKELIHOOD
OF POTENTIAL
ADVERSE EVENT
Unlikely
Unlikely
Unlikely
Unlikely
Very unlikely
Very unlikely
Very unlikely
Very unlikely
Very unlikely
Unlikely
Very unlikely
POTENTIAL
ADVERSE EFFECT
Skin injury, such as temporary
redness, discoloration or blisters
User delays known
effective treatments
Same as for adults, although the
severity of the effects may be
different.
User delays known
effective treatments
Blindness or temporary loss of
vision in the exposed eye
Serious eye or skin injury,
shock or electrocution
Skin injury, such as temporary
redness, discoloration or blisters
Skin injury, such as temporary
redness, discoloration or blisters
Skin injury, such as temporary
redness, discoloration or blisters
Worse acne or a minor skin
infection
Serious skin infection
LIKELIHOOD
OF POTENTIAL
ADVERSE EFFECT
Minor skin injury is
unlikely; major skin
injury is very unlikely.
Likely
Unknown because use on
children under 13 has not
been tested
Likely
Very unlikely
Very unlikely (same
as other common
electrical devices)
Minor skin injury is
unlikely; major skin
injury is very unlikely.
Minor skin injury is
unlikely; major skin injury
is very unlikely.
Minor skin injury is
unlikely; major skin
injury is very unlikely.
Unlikely
Unlikely
Tria Beauty 11