FDA 3649 Accidental Radiation Occurrence Report

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Devices and Radiological Health

Form Approved:
OMB Number 0910-0025
Expiration Date: January 31, 2017

ACCIDENTAL RADIATION OCCURRENCE REPORT

See Burden Statement on page 5.

Note: Items with an asterisk (*) require a response.

SUBMITTER INFORMATION
If you are not submitting this report representing the manufacturing establishment for the radiation-emitting product causing
the problem, you may enter your own company name under Establishment Identification and Submitter Address, or enter N/A
and provide your home or other address.
Contact Information
Contact Name (Title, first name, last name)*

Occupation Title

Email Address*

Establishment Identification (Manufacturer of the radiation-emitting product being reported, if known)
Establishment Name
Division Name

Submitter Address
Address

Telephone Number*

Street*
City*

State*

Fax Number

Zip Code*

INFORMATION REGARDING PRODUCT MANUFACTURER
Product Manufacturer Name (If known)
Product Manufacturer Address (If known)
Street (Line 1)

City

Product Model Designation (If known)

Street (Line 2)

Territory, Province, or State Country

Model Name or Number

Model Family Designation

Zip or Postal Code

Brand Name

Please provide any other information known regarding the manufacturer of the product that was involved in the accidental
radiation exposure incident.

If you are aware that the manufacturer was informed about the incident, please provide the contact information below.
Contact Information (Including whom you contacted and address)

FORM FDA 3649 (6/14)

PAGE 1 of 5

Date Contacted

PSC Publishing Services (301) 443-6740

EF

PRODUCT INFORMATION
Product Types (Please select the best match (only one). Note that product types are grouped into radiation categories.)
Acoustic Radiation

Microwave EMF Radiation (Continued)

Therapeutic Ultrasonic Devices (Including diathermy and
stimulators)

Microwave Identification, Safety, Security, and Surveillance
Products

Ultrasonic Medical Devices (Miscellaneous) (Including
lithotriptors)

Industrial Dielectric Heaters
Microwave Medical Products

Diagnostic Ultrasound Devices

Microwave Heating and Drying Products

Sonic Medical Products (Including hearing aids and
vibrators)

Microwave Communication, Data Transmit, and
Measurement Products (Including CB radios, cell phones,
walkie-talkies, household remote controllers)

Ultrasound Non-Medical Products (Including jewelry
cleaners and intrusion security systems)

Nuclear Magnetic Resonance Devices

Sonic Non-Medical Products

Household ELF Products (Including electric blankets)

Veterinary Diagnostic Ultrasonic Products

Other Microwave Product

Veterinary Therapy Ultrasonic Products

Optical Radiation

Other Sonic or Ultrasonic Product

Medical Laser Products (Including surgical devices and
laser therapy)

Ionizing Radiation
Personnel Security Systems (Including backscatter and
transmission x-ray systems)

Surveying, Leveling, Alignment Laser Products (Including
laser pointers, laser levels)

Cargo Non-Intrusive Security Systems

Laser Light Show/Display Products

Cabinet X-Ray Systems, Non-Medical (Including baggage
x-ray systems)

Toy, Novelty, Play Laser Products

Industrial X-Ray Systems (Excluding Cabinet)
Analytical X-Ray Systems, Non-Medical
High Voltage Vacuum Switches
Industrial Particle Beam Systems
TVs and video monitors (Not including flat-screen TVs)
Medical Diagnostic X-Ray Equipment
Dental Diagnostic X-Ray Equipment
Therapeutic X-Ray Systems
Veterinary X-Ray Systems

Safety, Security, Surveillance Laser Products (Including
night vision systems, traffic speed systems and intrusion
detection systems)
Research, Scientific, Laboratory Laser Products
Material Processing Laser Products (Including welders,
cutters, engravers)
Data Measurement, Transmit, Control Laser Products
(Including fiber optic communication systems, laser vision
systems and process control systems)
Utility/Peripheral Laser Products (Including laser printers,
bar code scanners, CD and DVD systems)

X-Ray Bone Densitometers

In Vitro and Other Medical Laser Products (Including
Veterinary devices)

X-Ray Film and Film Processing Materials

Patient Positioning Medical Laser Products

Cabinet X-Ray Systems, Medical

Other Laser Products

Medical Accelerators

Sunlamp Products (Including sunlamps and tanning beds)

Non-Medical Accelerators

Mercury Vapor Lamps

High Voltage Vacuum Tubes

Ultraviolet Medical Products

Cathode Ray Tube (Without Electronics Chassis)

Ultraviolet Commercial/Consumer Products

Cold-Cathode Gas Discharge Tubes

Ultraviolet Surveillance & Detection Products

Other X-Ray Product

Ultraviolet Hygiene Products (Including UV sanitizers)

Microwave EMF Radiation
Microwave Ovens (Food Prep)
Microwave Hyperthermia Therapy Devices

General Optical Products, Medical (Including surgical
lamps)
General Optical Products, Non-Medical (Including LEDs
and fluorescent lamps)

Microwave Diathermy Machines
FORM FDA 3649 (6/14)

PAGE 2 of 5

PRODUCT INFORMATION (Continued)
Product Description
Description of product and its intended use

ACCIDENTAL RADIATION OCCURRENCE INFORMATION
Location of Occurrence

Please provide the physical location where the Accidental Radiation Occurrence took place (e.g., at a residence, a factory, a
tanning salon, school, restaurant, airport, etc.). If you do not know the exact address, provide responses to the best of your
ability, or enter "Unknown."
Location or Establishment Name
Specific Section of Location or Establishment (If applicable)
Address
Street

Telephone Number

City
Date of Event*

State
From

To

Zip Code

Fax Number

Web Address

Persons Involved
Number of people exposed in the
Accidental Radiation Occurrence*

Type of reportable event

Number of people
adversely affected*

Death

Number of unexposed
Number of potentially exposed people
people who were involved* who have not exhibited any adverse
reactions*

Serious Injury

Malfunction

Description of the nature and magnitude of exposure and/or injuries

FORM FDA 3649 (6/14)

PAGE 3 of 5

Other

.

ACCIDENTAL RADIATION OCCURRENCE INFORMATION (Continued)
Description of the Radiation Occurrence
Is this a new Accidental Radiation Occurrence (ARO) report or a supplement to a previous ARO report filed by you or your organization?
(Please select one.)*
New ARO report

Supplement to previous ARO report (Enter date of previous report below.)

Date of previous ARO report, if applicable (mm/dd/yyyy) (Required entry* only if “Supplement to previous ARO report” is selected.)
Description of circumstances surrounding the accidental radiation occurrence (Please include a description of the activities leading
up to the event and actions that occurred during the event, as well as any suspected causes of the occurrence.)*

Actions Taken
The actions described below are those taken to control, correct, or eliminate the causes and to prevent reoccurrence. If
unknown, you may state "Unknown" below.
Description of specific actions, to date, taken by the manufacturer in response to the Accidental Radiation Occurrence*

FORM FDA 3649 (6/14)

PAGE 4 of 5

ACCIDENTAL RADIATION OCCURRENCE INFORMATION (Continued)
Actions Taken (Continued)
Description of future actions to be taken by the manufacturer, if known, in response to the Accidental Radiation Occurrence (If this is a
preliminary ARO report from the manufacturer, please indicate that further investigation is ongoing.)*

If this involved a medical device, has a Medical Device Report (MDR) been submitted to FDA?*
Yes

No

N/A

Unknown

Other Important Information (Please enter below)

Feel free to send in medical documentation regarding the incident and injuries.

Please mail this completed FORM FDA 3649
to the address to the right:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 2 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
FORM FDA 3649 (6/14)

PAGE 5 of 5

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