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Medical Devices Sector
MDPRC
Medical Devices Problem Reporting Center
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Report a Devices Problem
Personal Information

Your personal and organization identities will not be revealed in any way without your permission.
Title:
First Name: *
Last Name: *
Organization: *
Department:
Address: *
 
City: *
State or Province:
Postal Code: *
Phone: *
Fax:
Email: *
Website URL:
May we identify you to the manufacturer and/or supplier of the device(s) involve?:
Devices Information

Please be as specific as possible in identifying the devices involved. Please add any other information that might be helpful, and omit items that are not known or that appear to be irrelevant to this particular problem.

Type(s) of devices(s) involved: *
Manufacturer: *
Local Supplier/Distributor: *
Model: *
Serial/Lot No.: *
Expiration/Used Before Date:
How long in use:
Condition:
Date problem occurred:
(M/d/yyyy) CE
*
Date last inspected or serviced:
(M/d/yyyy) CE
Where there other devices involved?:
If yes, please describe:
Are the devices available for inspection?:
If a single-use devices were involved, were they reprocessed at any time before the incident?:
Are other units of the same model similarly effected?:
Problem Description
Outcome of the problem:
If other:

Please use the following text box to describe the hazard or problem in detail. Include how it was discovered, any action you took, and the response of any suppliers or manufacturers. Please also mail or fax any related correspondence when possible. Sketches, photographs, or copies of portions of operating manuals are often helpful in describing the problem, especially if the affected devices are not available for examination at SDFA. Retain all disposable accessories involved in an incident. Please do not send any devices to SFDA until requested.

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