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This document serves as an urgent field safety notice addressing an issue with the METS Tibial Rotating Hinge: Metal Cased Assembly, specifically regarding the incorrect packaging of the product that
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How to fill out field safety notice
How to fill out Field Safety Notice
01
Start with the header that identifies it as a Field Safety Notice.
02
Provide the date of issue in the designated field.
03
Include the product name and model number.
04
Describe the safety issue clearly and concisely.
05
Include detailed instructions for the necessary actions to be taken.
06
Specify the persons to contact for further information.
07
Make sure to list the affected batch numbers or lot codes.
08
State the deadline for response or action, if applicable.
09
Review the notice for clarity and completeness.
10
Distribute the notice to all relevant parties.
Who needs Field Safety Notice?
01
Healthcare providers who utilize the affected product.
02
Patients who are using or may be affected by the product.
03
Regulatory bodies monitoring product safety.
04
Distributors and retailers involved in the product supply chain.
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People Also Ask about
What is a FSCA in medical devices?
A field safety corrective action (FSCA) is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of an IVD that is already placed on the market.
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 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
How to report FSCA in EU?
The manufacturer or AR must notify the CA of all affected countries — as well as the national CA where the manufacturer or their AR is located — for any FSCA conducted in the EU. You can find the FSCA report form on the European Commission website along with a template field safety notice (FSN).
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 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
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 the full form of FSCA?
The Financial Sector Conduct Authority (FSCA) is responsible for market conduct regulation and supervision.
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 a FSCA in medical devices?
A field safety corrective action (FSCA) is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of an IVD that is already placed on the market.
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What is Field Safety Notice?
A Field Safety Notice (FSN) is a communication issued by a manufacturer to inform users about safety issues related to a specific medical device or product. It alerts users to take necessary actions to ensure safety.
Who is required to file Field Safety Notice?
Manufacturers of medical devices are required to file a Field Safety Notice if they identify a safety issue that could affect the performance or safety of their product.
How to fill out Field Safety Notice?
To fill out a Field Safety Notice, manufacturers should include essential details such as the device identification, description of the issue, actions to be taken by users, and any necessary contact information for further queries.
What is the purpose of Field Safety Notice?
The purpose of a Field Safety Notice is to ensure that users are warned of potential safety issues, to provide instructions on how to mitigate risks, and to promote the safe use of medical devices.
What information must be reported on Field Safety Notice?
The information that must be reported on a Field Safety Notice includes the product's identification details, description of the safety issue, recommendations for users, corrective actions required, and contact information for the manufacturer.
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