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
If yes, please provide postmortem 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.