Medwatch - Instructions For Medwatch Form 3500 - Voluntary Reporting Of Adverse Events Page 10
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18MedWatch - Instructions for MedWatch Form 3500
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For a product problem: Describe the problem (quality, performance, or safety
concern) in sufficient detail so that the circumstances surrounding the defect or
malfunction of the medical product can be understood.
If available, the results of any evaluation of a malfunctioning device and, if
known, any relevant maintenance/service information should be included
in this section
For a medication or special nutritional product problem, please indicate if
you have retained a sample that would be available to FDA
For a product use error: (see B1 above): Describe the sequence of events
leading up to the error in sufficient detail so that the circumstances surrounding
the error can be understood.
For Medication Use Errors: Include a description of the error, type of staff
involved, work environment in which the error occurred, indicate causes or
contributing factors to the error, location of the error, names of the products
involved (including the trade (proprietary) and established (proper) name,
manufacturer, dosage form, strength, concentration, and type and size of
container.
For Medical Device Use Errors: 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
For a problem with a different manufacturer of the same medicine (see B1
above):
Please include 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 manufacturer's product, product
strength, and any relevant clinical data.
Return to Index
B6:
Relevant Tests/Laboratory Data, Including Dates
Please provide all appropriate information, including relevant negative test and
laboratory findings, in order to most completely convey how the medical
work-up/ assessment led to strong consideration of medical product-induced
disease as etiology for clinical status, as other differential diagnostic
considerations were being eliminated.
Please include:
8/8/2006 1:41 PM
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