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This notice informs users about the recall of CONNED\'s Thermoform® Dual Dispersive Electrodes due to compatibility issues with certain electrosurgical generators, posing patient risks.
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Start by obtaining the necessary form for the field safety notice.
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Fill out all required fields with accurate and detailed information related to the safety notice.
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Include any relevant supporting documents or evidence with the field safety notice.
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Who needs field safety notice?
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Any organization or individual who has identified a safety concern related to a product or service that poses a risk to the health and safety of consumers or users may need to file a field safety notice.
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What is field safety notice?
A field safety notice is a communication issued by a manufacturer or regulatory authority to inform users about potential safety issues with a medical device or product, including instructions for corrective action.
Who is required to file field safety notice?
The manufacturer or authorized representative of the medical device is required to file a field safety notice.
How to fill out field safety notice?
To fill out a field safety notice, you must provide clear and accurate information about the device, the safety issue, corrective actions, affected product details, and instructions for users.
What is the purpose of field safety notice?
The purpose of a field safety notice is to inform affected parties about safety concerns, to guide them in taking necessary actions to mitigate risks, and to ensure the safety and effectiveness of the product.
What information must be reported on field safety notice?
The field safety notice should include the device identification, details of the safety issue, potential risks, actions to be taken, contact information for further assistance, and a timeline for reporting back.
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