Which Sections of the MedWatch 3500A Form Are Filled In?

Not all sections of the MedWatch 3500A are filled in for every report. Which sections are filled in depends upon the Event Type and Facility Type fields. The Event Type field is in the More Info view of the Regulatory Reports screen. The Facility Type field is in the Importer view of the Regulatory Reports screen.

These sections always are filled in:

• A. Patient Information

• B. Adverse Event or Product Problem

• E. Initial Reporter

  The following table describes the conditions for which the other sections get filled in.

  If...	And...	These sections are filled in...	And these sections can remain blank...
  Event Type = Adverse Event Drug, Product Problem Drug, or AE and PP Drug	—	C G	D F H
  Event Type = Adverse Event Device, Product Problem Device, or AE and PP Device	Facility Type = NULL (blank)	D G H	C F
  Event Type = Adverse Event Device, Product Problem Device, or AE and PP Device	Facility Type = User Facility, Distributor, or Importer (That is, not blank)	D F G	C H