Medwatch - Instructions For Medwatch Form 3500 - Voluntary Reporting Of Adverse Events Page 9
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18MedWatch - Instructions for MedWatch Form 3500
9 of 18
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B3:
Date of Event
Provide the actual or best estimate of the date of first onset of the adverse
event. If day is unknown, month and year are acceptable. If day and month are
unknown, year is acceptable.
When a newborn baby is found to have a congenital anomaly, the event
onset date is the date of birth of the child
When a fetus is aborted because of a congenital anomaly, or is
miscarried, the event onset date is the date pregnancy is terminated
If information is available as to time during pregnancy when exposure occurred,
indicate that information in narrative block B5.
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B4:
Date of this Report
The date the report is filled out.
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B5:
Describe Event, Problem or Product Use Error
For an adverse event:
Describe the event in detail, including a description of what happened and a
summary of all relevant clinical information (medical status prior to the event;
signs and/or symptoms; differential diagnosis for the event in question; clinical
course; treatment; outcome, etc.). If available and if relevant, include synopses
of any office visit notes or the hospital discharge summary. To save time and
space (and if permitted by your institution), please attach copies of these
records with any confidential information deleted. Do not identify any patient,
physician, or institution by name. The reporter's identity should be
provided in full in section E.
Information as to any environmental conditions that may have influenced the
event should be included, particularly when (but not exclusive to) reporting
about a device.
Results of relevant tests and laboratory data should be entered in block
B6. (See instructions for B6).
Preexisting medical conditions and other relevant history belong in block
B7. Be as complete as possible, including time courses for preexisting
diagnoses (see instructions for B7).
If it is determined that reuse of a medical device labeled for single use may have
caused or contributed to an adverse patient outcome, please report in block B5
the facts of the incident and the perceived contribution of reuse to the
occurrence.
8/8/2006 1:41 PM
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