In the reporter’s opinion (if a HCP) was the event:
Event abated after the suspect
product was discontinued or
Event reappeared after
reintroduction of the suspect
Post Mortem Performed:
If yes, please provide post mortem results (if known)
If female, Pregnant?
Relevant Lab Data
Relevant Medical History
History of Allergies
Reporter Causality Assessment:
Permission to contact reporter for additional information:
Permission to contact Health Care Professional (HCP), if different from Reporter:
If this procedure is printed copy it shall become obsolete after 24hrs.