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This document is a safety notice issued by Edwards Lifesciences regarding certain surgical heart valve models that may contain metallic particles due to a packaging issue. It outlines the actions
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How to fill out field safety notice
How to fill out Field Safety Notice
01
Begin by identifying the product involved in the safety notice.
02
Clearly describe the nature of the safety issue and any potential risks associated with the product.
03
Provide detailed instructions on how to address the safety issue, including any necessary steps for users.
04
Include contact information for further inquiries or support.
05
Ensure that the notice is distributed to all relevant stakeholders, including customers and regulatory bodies.
Who needs Field Safety Notice?
01
Healthcare professionals who use the product.
02
Distributors and retailers who sell the product.
03
Regulatory authorities overseeing product safety.
04
Patients or end-users of the affected product.
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People Also Ask about
What are the field safety corrective actions?
Here are a few other corrective action examples that specifically deals with workplace safety and business security: Providing equipment upgrades. Implementing safety training. Conducting regular and random safety audits.
What is a field safety notice?
Field Safety Notice. A communication sent out by a manufacturer or its representative to the device users in relation to a Field Safety Corrective Action.
What is an example of a safety corrective action?
Examples of corrective actions in food safety include discarding food that has been stored improperly, retraining staff on hygiene practices, and adjusting cooking or cooling methods to ensure safety standards are met.
What is a field safety notification?
A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action.
What is a FSCA in MDR?
A Field Safety Corrective Action (FSCA) is defined in Article 2(68) of Regulation (EU) 2017/745 on medical devices (MDR) and Article 2(71) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) as a corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce the
What is an example of a corrective action in ?
Corrective actions address an existing issue by identifying and eliminating its root cause to prevent recurrence. For example, if a machine breaks down due to poor maintenance, a corrective action would involve fixing the machine and improving the maintenance schedule.
What is an example of a field safety corrective action?
The FSCA may include; the return of a medical device to the supplier, device modification, device exchange, device destruction, retrofit by purchaser of manufacturer's modification or design change, advice given by manufacturer regarding the use of the device (e.g. where the device is no longer on the market or has
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What is Field Safety Notice?
A Field Safety Notice is a communication issued by a manufacturer to inform users and healthcare professionals about safety issues related to a medical device. It provides instructions on how to manage or mitigate risks associated with the device.
Who is required to file Field Safety Notice?
Manufacturers of medical devices are required to file a Field Safety Notice when they identify safety issues that could affect the health or safety of patients or users.
How to fill out Field Safety Notice?
To fill out a Field Safety Notice, manufacturers must provide detailed information including device identification, description of the issue, recommended actions for users, and relevant contact information.
What is the purpose of Field Safety Notice?
The purpose of a Field Safety Notice is to ensure patient safety by notifying users about potential risks associated with a medical device, providing guidance on corrective measures, and complying with regulatory requirements.
What information must be reported on Field Safety Notice?
Information that must be reported on a Field Safety Notice includes device identification, description of the safety issue, potential consequences, recommended actions, and manufacturer contact information.
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