(FOM019/HPT/VMS/SOP/001)

in confidenceCOA

MINISTRY OF HEALTH

PHARMACY AND POISONS BOARD
P.O. Box 27663-00506 NAIROBI
Tel: +254795743049
Email: pv@ppb.go.ke/medicaldevices@pharmacyboardkenya.org
MEDICAL DEVICES INCIDENT REPORTING FORM

Tip: Fields marked with * are mandatory

Form ID: new
Initial (Initial Report: new)

PATIENT INFORMATION
*--OR--

(specify)

(self or nearest contact)


Kg
cm

Device/In vitro Diagnostic information
clear!

(catheter; syringe 5cc,10cc; latex gloves etc.)

(dd-mm-yyyy)

(dd-mm-yyyy)


clear!
clear!

4. How long was the device/ equipment/ machine in use

-
clear!
clear!

7. For implants only (e.g. intrauterine devices, pacemakers)

(dd-mm-yyyy)

(dd-mm-yyyy)

Duration of implantation (to be filled if the exact implant and explant dates are unknown):

-

8. For diagnostics only (including machines and equipment e.g. rapid diagnostic test kits, glucometer)

(e.g. blood, saliva, etc):


9. List of other/associated devices involved in the event

#

Incident information
clear!

Reason for seriousness:

clear!


clear!

Do you have pictures or documents that you would like to send to PPB? click on the button to add them:
# File Text Description
Is the person submitting different from reporter?