Medwatch - Instructions For Medwatch Form 3500 - Voluntary Reporting Of Adverse Events Page 17
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18MedWatch - Instructions for MedWatch Form 3500
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Please indicate whether you have also notified or submitted a copy of this report
to the manufacturer and/or distributor of the product, or, in the case of medical
device reports only, to the user facility (institution) in which the event occurred.
This information helps to track duplicate reports in the FDA database.
Return to Index
G5: Release of reporter's identify to the manufacturer
In the case of a serious adverse event, FDA may provide name, address and
phone number of the reporter denoted in block G1 to the manufacturer of the
suspect product. If you do not want your identity released to the manufacturer,
please put an X in this box.
Return to Index
APPENDIX I
ROUTES OFADMINISTRATION: ICH LIST AND CODES
ICH-M2 Numeric
Description
Codes
Auricular (otic)
001
Buccal
002
Cutaneous
003
Dental
004
Endocervical
005
Endosinusial
006
Endotracheal
007
Epidural
008
Extra-amniotic
009
Hemodialysis
010
Intra corpus cavernosum
011
Intra-amniotic
012
Intra-arterial
013
Intra-articular
014
Intra-uterine
015
Intracardiac
016
Intracavernous
017
Intracerebral
018
Intracervical
019
Intracisternal
020
Intracorneal
021
Intracoronary
022
Intradermal
023
Intradiscal (intraspinal)
024
Intrahepatic
025
Intralesional
026
Intralymphatic
027
Intramedullar (bone marrow)
028
8/8/2006 1:41 PM
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