المؤسسة العامة للغذاء و الدواء
Adverse Incident Reporting Form
Report Details
Reporting body
*
hospital
pharmacy
health care center
others
Report name
*
Position
Address
Country
select Country
Abkhazia
Afghanistan
Aland Islands
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antigua & Barbuda
Argentina
Armenia
Aruba
Ascension Island
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bosnia/Herzegovina
Botswana
Brazil
British Indian Ocean Territory
British Virgin Islands
Brunei
Bulgaria
Burkina Faso
Burundi
Côte d'Ivoire
Cambodia
Cameroon
Canada
Canary Islands
Cape Verde Islands
Caribbean Netherlands
Cayman Islands
Central African Republic
Ceuta and Melilla
Chad Republic
Chile
China
Christmas Island
Cocos Keeling Island
Colombia
Comoros
Congo-Brazzaville
Congo-Republic of
Cook Islands
Costa Rica
Croatia
Cuba
Curaçao
Cyprus
Czech Republic
Denmark
Diego Garcia
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Ethiopia
Falkland Islands
Faroe Island
Fiji Islands
Finland
France
French Antilles/Martinique
French Guiana
French Polynesia
French Southern and Antarctic
Gabon Republic
Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea Republic
Guinea-Bissau
Guyana
Haiti
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iraq
Ireland
Isle of Man
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
Korea Republic of
Kuwait
Kyrgyzstan
Laos
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
Macau
Macedonia
Madagascar
Malawi
Malaysia
Maldives
Mali Republic
Malta
Marshall Islands
Mauritania
Mauritius
Mayotte
Mexico
Micronesia
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar (Burma)
Namibia
Nauru
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Niger Republic
Nigeria
Niue Island
Norfolk
North Korea
Norway
Oman Dem Republic
Pakistan
Palau Republic
Palestine
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn Islands
Poland
Portugal
Qatar
Reunion Island
Romania
Russian Federation
Rwanda Republic
Saipan/Mariannas
Samoa
San Marino
Sao Tome/Principe
Saudi Arabia
Senegal
Serbia
Seychelles Island
Sierra Leone
Singapore
Slovakia
Slovenia
Solomon Islands
Somalia Republic
Somaliland
South Africa
Spain
Sri Lanka
St. Helena
St. Kitts
St. Lucia
St. Pierre
St. Vincent
Sudan
Suriname
Svalbard and Jan Mayen
Swaziland
Sweden
Switzerland
Syria
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo Republic
Tokelau
Tonga Islands
Transnistria
Trinidad & Tobago
Tristan da Cunha
Tunisia
Turkey
Turkmenistan
Turks & Caicos Island
Tuvalu
Uganda
Ukraine
United Arab Emirates
United Kingdom
Uruguay
USA
Uzbekistan
Vanuatu
Venezuela
Vietnam
Virgin Islands (US)
Wallis/Futuna Islands
Western Sahara
Yemen Arab Republic
Zambia
Zimbabwe
*
Telephone
Mobil phone
*
Consultant-in-charge
This report confirms
Telephone report
Fax report
Neither
Type of device
Active implantable devices
External defibrillators & pacemakers
Patient hoists
Administration & giving sets
Feeding tubes
Physiotherapy equipment
Anaesthetic machines & monitors
Gloves
Radiotherapy equipment
Anaesthetic & breathing masks
Guidewires
Radionuclide equipment
Autoclaves
Hearing aids
Resuscitators
Bath aids
Hypodermic syringes & needles
Staples & staple guns
Beds & mattresses
Implant materials
Stretchers
Blood pressure measurement
Infant incubators
Surgical instruments
Breast implants
Infusion pumps, syringe drivers
Surgical power tools
Cardiovascular implants & devices
Intravenous catheters & cannulae
utures
Commodes
Joint prostheses
Thermometers
Contact lenses & care products
Lasers & accessories
Ultrasound equipment
CT systems
Magnetic resonance equipment & accessories
Urinary catheters
Dental materials & appliances
Dental materials & appliances
Ventilators
Dialysis equipment
Mobile x-ray systems
Walking sticks / frames
Diathermy equipment & accessories
Monitors & electrodes
Wound drains
Dressings
Non-active implants
X-ray equipment, systems & accessories
Endoscopes & accessories
Ophthalmic equipment
Endotracheal tubes & airways
Other (specify)
*
Details of device
Product:
Invoice No
Catalogue No
Serial No
Model
Manufacturer
Telephone no:
Batch no.
Supplier
Manufacturing date:
Expiry date:
Location of device now
Quantity defective
Is there a CE-mark/or FDA ?
Yes
No
If YES, was the manufacturer or supplier contacted?
Yes
No
Was there a fatality?
Yes
No
Was an injury caused?
Yes
No
Consequences of suspected reactions
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
Reqiured intervention to prevent impairment/damage( Device)
Persistent disability
Leading to congenital anomaly
Other serious consequences
Specify:
Important Medical events
Nature of defect / details of incident:
Attachments
Contact for further details
Name:
Phone:
Action taken by staff / manufacturer / supplier:
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