40 Revision 02, January 2011
12. A
DVERSE
E
VENTS
R
EPORT
F
ORM
Date of Report ________________
In the case of any of the adverse events listed below, please complete this
form and send a copy to your distributor and Radiancy Ltd. no longer than
24-48 hours after you learn of the occurrence. Retain a copy for your own
records.
Radiancy (Israel) Ltd.
5 Hanagar St., P.O. Box 7329
Hod Hasharon, 45240
Israel
FAX: 972-9-775-7511
[email protected]
Adverse Event
- Any unwanted medical occurrence in a subject whether or
not it is device related.
Outcomes attributed to the adverse event
:
Hospitalization (mm/dd/yy) _______ / _______ / _______
Required intervention to prevent permanent impairment/damage
Disability or permanent damage
Death (mm/dd/yy) _______ / _______ / _______
Other serious (important medical events)
Client Information :
First Name: ____________________
Last Name: ____________________
Age: _____
Gender : Female
Male
Treatment Administration :
Date of event: (mm/dd/yy) _______ / _______ / _______
Submission of a report does not constitute an admission of fault or
that the medical personnel, facility, importer, manufacturer or product
caused or contributed to the event
