Professional Documents
Culture Documents
Life-Threatening:
Report if the person
was at substantial
risk of dying at time
of the adverse
event or if
suspected that
continued use of
product could result
in a persons death.
Hospitalization:
Report if admission
to the hospital was
caused by or related
to an adverse event
associated with use
of the product.
Emergency Room
treatment is
sometimes reported
too.
Disability: Report if
the adverse event
resulted in a
significant or
permanent change,
impairment or
damage to the
persons body
function/structure or
quality of life.
Spontaneous
abortion,
congenital
anomaly or birth
defect associated
with a product use
must also be
reported to the FDA.
FDA encourages
healthcare professionals
to report serious adverse
events to the agency for
tracking purposes.
CFSAN encourages
voluntary AE reports for
cosmetics and
conventional foods.
If a company receives a
report of a serious
adverse event, you
should report it to CAERS
even if reporting isnt
mandatory for the
product (e.g. a food or
cosmetic).
FDA Notifications
Many serious adverse
events are reported to
FDA directly by
consumers, hospitals,
or healthcare
professionals.
If FDA receives a
serious adverse event
report about a
companys product
they will contact you
and you must keep
that report on file.
Often FDA notification
comes with a request
for more information
and submission of a
Medwatch form with
product label.
Click on
Download form
or click on
Recalls &
Alerts and see
bullet called
MEDWATCH.
Click on Report
serious adverse
events online.
Or http://www.fda.gov/Safety/MedWatch/default.htm
Thank You