PvERS: the Pharmacovigilance Electronic Reporting System: Devices

Initial Report ID: new

(FOM019/HPT/VMS/SOP/001)

MINISTRY OF HEALTH

PHARMACY AND POISONS BOARD

P.O. Box 27663-00506 NAIROBI

Tel: +254795743049

Email: pv@pharmacyboardkenya.org/medicaldevices@pharmacyboardkenya.org

MEDICAL DEVICES INCIDENT REPORTING FORM

Tip: Fields marked with * are mandatory

Form ID: new

REPORT TITLE

Initial (Initial Report: new)

NAME OF INSTITUTION/ ORGANZIATION *

PHYSICAL ADDRESS

INSTITUTION CODE

CONTACT

COUNTY *

PATIENT INFORMATION

PATIENT'S NAME/ INITIALS *

IP/OP NO.

DATE OF BIRTH

*--OR--

Age group

ANY KNOWN ALLERGY

YesNo clear!

(specify)

PATIENT ADDRESS

PHONE NUMBER

(self or nearest contact)

GENDER *

MaleFemale clear!

PREGNANCY STATUS

Not ApplicableNot pregnant

1st Trimester2nd Trimester3rd Trimester clear!

WEIGHT (kg)

HEIGHT (cm)

Device/In vitro Diagnostic information

1. PROBLEM NOTED PRIOR TO USE *

YesNo clear!

BRAND NAME/ COMMERCIAL NAME *

COMMON NAME

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

MODEL

NAME OF MANUFACTURER *

SERIAL/ LOT NO. *

CATALOGUE NUMBER

MANUFACTURER ADDRESS

DEVICE MANUFACTURE DATE *

(dd-mm-yyyy)

EXPIRY DATE *

(dd-mm-yyyy)

2. Operator of the device at time of onset

Healthcare professionalPatientCaregiverOther clear!

Other (specify)

3. Usage of device (choose whichever applies)

Single useReuse of reusableReuse of single-useReserviced/Refurbished clear!

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

5. Availability of device for evaluation

YesNo clear!

If No

Device destroyedStill in useReturned to manufacturer/importer/distributor clear!

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

Implant date

(dd-mm-yyyy)

Explant date

(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)

Type of specimen used

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

No. of patients involved

No. of false negatives

No. of tests done

No. of true positives

No. of false positives

No. of true negatives

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

Brand Name/Commercial Name*		Serial/Lot No.*	Common Name*	Manufacturer's Name*	Manufacture Date*	Expiry date*	#

Incident information

Date of onset of the incident *

Event classification *

FatalSeriousModerateMildUnknown clear!

Reason for seriousness:

Death - Life-threateningHospitalization or prolongation of existing hospitalizationResults in persistent or significant disabilityCongenital anomaly or birth defect clear!

Description of event

Remedial Action/Corrective action/preventive action taken by the healthcare facility relevant to the care of the patient

Patient Outcome *

Do you have pictures or documents that you would like to send to PPB? click on the button to add them:

#	File	Text Description

Name of Person Reporting *

E-MAIL ADDRESS *

DESIGNATION *

PHONE NO. *

Date *

Is the person submitting different from reporter?

Yes No

Name of initial reporter*

E-MAIL ADDRESS *

Designation *

PHONE NO.

Date of Initial report

MINISTRY OF HEALTH

PHARMACY AND POISONS BOARD

P.O. Box 27663-00506 NAIROBI

Tel: +254795743049

Email: pv@pharmacyboardkenya.org/medicaldevices@pharmacyboardkenya.org

MEDICAL DEVICES INCIDENT REPORTING FORM

Form ID: new

PATIENT INFORMATION

*--OR--

Device/In vitro Diagnostic information

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

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

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

Incident information

Do you have pictures or documents that you would like to send to PPB? click on the button to add them:

Is the person submitting different from reporter?

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