JFDA- ADVERSE INCIDENT REPORT FORM
REPORT
Reporting body…………hospital…………health care center……pharmacy………others…
Address………………………………………………………………………………….………...
Report name………………………………………………………………………….………….
Position………………………………………………………………...……………………
Telephone number…………………………………………………………………………..
Consultant-in-charge (if known) ……………………………………………………………
This report confirms a telephone report 
a fax report 
neither 
Type of device: (tick one only)
 Active implantable devices
 External defibrillators &
pacemakers
 Physiotherapy equipment
 Administration & giving sets
 Feeding tubes
 Radiotherapy equipment
 Anaesthetic
monitors
machines
 Gloves
 Radionuclide equipment
 Anaesthetic
masks
&
 Guidewires
 Resuscitators
 Autoclaves
 Hearing aids
 Staples & staple guns
 Bath aids
 Hypodermic
needles
 Beds & mattresses
 Implant materials
 Surgical instruments
 Blood pressure measurement
 Infant incubators
 Surgical power tools
 Breast implants
 Infusion
drivers
 Cardiovascular implants &
devices
 Insulin syringes
 Commodes
 Intravenous
cannulae
 Contact
products
 CT systems
lenses
&
breathing
&
care
syringes
pumps,
&
syringe
 Stretchers
 Sutures
 Thermometers
catheters
&
 Ultrasound equipment
 Joint prostheses
 Urinary catheters
 Lasers & accessories
 Ventilators
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
Dental
appliances

Magnetic
resonance
equipment & accessories
 Walking sticks / frames
 Mobile x-ray systems
 Wound drains
 Monitors & electrodes
 X-ray equipment, systems & accessories
 Dressings
 Non-active implants
 Other (please specify)
 Endoscopes & accessories
 Ophthalmic equipment
materials
&
 Dialysis equipment
 Diathermy equipment
accessories
&
.......................................
 Endotracheal
airways
tubes
&
 Patient hoists
Further details can be given on additional sheets if necessary
MEDICAL DEVICES
Details of device:
Invoice No.
Product
Catalogue No.
Model
Serial No.
Manufacturer
Telephone no:
Supplier
Batch No
Expiry date
Date of mfr
Quantity defective
Location of device now
Is there a CE-mark/or FDA ? YES 
Was there a fatality? YES 
NO 
NO 
If YES, was the manufacturer or supplier contacted?
Was an injury caused?
YES 
YES 
NO 
Consequences of Product problem (s).
Serious: □ Yes □ No. If serious please indicate the seriousness of reaction (s).
□ Death (Date of death …………….. Cause of death ………………………………….)
□ Life threatening
□ Hospitalization – initial or prolonged
□Leading to congenital anomaly
□ Persistent disability □Reqiured intervention to prevent impairment / damage ( Device) □ Other serious consequences
(important Medical events …………………)
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NO 
Nature of defect / details of incident:
Contact name for further details
Telephone number
Action taken by staff / manufacturer / supplier:
.......................................................................…………………………….
Signed ......................................................... Date ..............................
Please send completed form to JORDAN FOOD AND DRUG ADMNISTRATION AMMAN-JORDAN TEL. 4602000 TELEFAX : + 962 – 6- 4
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