Medwatch - Instructions For Medwatch Form 3500 - Voluntary Reporting Of Adverse Events Page 7
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18MedWatch - Instructions for MedWatch Form 3500
7 of 18
system, which includes selecting and procuring drugs, prescribing, preparing
and dispensing, administering and monitoring. A medication error is defined as
“any preventable event that may cause or lead to inappropriate medication use
or patient harm while the medication is in the control of the health care
professional, patient, or consumer. Such events may be related to professional
practice, health care products, procedures, and systems, including prescribing,
order communication, product labeling, packaging, nomenclature, compounding,
dispensing, distribution, administration, education, monitoring and use.”
Medical Device Use Error: Health care professionals, patients, and consumers
can unintentionally cause harm to patients or to themselves when using medical
devices. These problems can often arise due to problems with the design of the
medical device or the manner in which the device is used. Often use-errors are
caught and prevented before they can do harm (close call). Report use errors
regardless of patient involvement or outcome. Also report circumstances or
events that could cause use errors. Medical device use errors usually occur for
one or more of the following reasons:
Users expect devices to operate differently than they do
Product use is inconsistent with user’s expectations or intuition
Product use requires physical, perceptual, or cognitive abilities that
exceed those of the user
Devices are used in ways not anticipated by the manufacturer
Product labeling or packaging is confusing or inadequate
The environment adversely effects or influences device use
Problem with Different Manufacturer of Same Medicine: Any incident, to
include, but not limited to, differences in noted therapeutic response, suspected
to have resulted from a switch, or change, from one manufacturer to another
manufacturer of the same medicine or drug product. This could be changes
from a brand name drug product to a generic manufacturer's same product, or
from a generic manufacturer's product to the same product as supplied by a
different generic manufacturer, or from a generic manufacturer's product to a
brand name manufacturer of the same product. In order to fully evaluate the
incident, please include in Section B5, if available, specific information relative
to the switch between different manufacturers of the same medicine, to include,
but not limited to, the names of the manufacturers, length of treatment on each
manufacture's product, product strength, and any relevant clinical data.
Return to Index
B2:
Outcomes Attributed to Adverse Event: Indicate all that apply to the reported
event:
Death: Check only if you suspect that the death was an outcome of the adverse
event, and include the date if known.
Do not check if:
The patient died while using a medical product, but there was no
suspected association between the death and the use of the product
A fetus is aborted because of a congenital anomaly (birth defect), or is
miscarried
8/8/2006 1:41 PM
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