Medwatch - Instructions For Medwatch Form 3500 - Voluntary Reporting Of Adverse Events Page 4
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18MedWatch - Instructions for MedWatch Form 3500
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D3:
Dates of Use
D4:
Diagnosis or Reason for Use
D5:
Event Abated After Use Stopped or Dose Reduced
D6:
Lot #
D7:
Expiration date
D8:
Event Reappeared After Reintroduction
D9:
NDC # or Unique ID
SECTION E:
SUSPECT MEDICAL DEVICE
E1:
Brand Name
E2:
Common Device Name
E3:
Manufacturer Name, City and State
E4:
Model #, Catalog #, Serial #, Lot #, Expiration date
E5:
Operator of Device
E6:
If Implanted, Give Date
E7:
If Explanted, Give Date
E8:
Reprocessed and Reused on a Patient?
E9:
Name and Address of Reprocessor
SECTION F:
OTHER (CONCOMITANT) MEDICAL PRODUCTS
SECTION G:
REPORTER
G1:
Name, Address, Phone #, Email
G2:
Health Professional?
G3:
Occupation
G4:
Also Reported to:
G5:
Release of Reporter's Identity to the Manufacturer
APPENDIX I:
ROUTES OF ADMINISTRATION: ICH LIST AND CODES
SECTION A: PATIENT INFORMATION
Complete a separate form for each patient, unless the report involves a medical device
where multiple patients were adversely affected through the use of the same device. In that
case, please indicate the number of patients in block B5 (Describe event or problem) and
complete Section A and blocks B2, B5, B6, B7, and F for each patient. Enter the
corresponding patient identifier in block A1 for each patient involved in the event.
Parent-child/fetus report(s) are those cases in which either a fetus/breast-feeding infant or
the mother, or both, have an adverse event that is possibly associated with a product
administered to the mother during pregnancy. Several general principles are used for filing
these reports:
If there has been no event affecting the child/fetus, report only on the parent.
For those cases describing fetal death, miscarriage or abortion, report the parent as
the patient in the report.
When only the child/fetus has an adverse reaction/event (other than fetal death,
miscarriage or abortion ), the information provided in section A applies to the
child/fetus. However, the information in section D would apply to the parent who was
the source of exposure to the product.
8/8/2006 1:41 PM
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