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URGENTFIELDSAFETYNOTICE/MITRACLIPXTR PHYSICIANADVISORY ___ COMMERCIALISM:MitraClipXTRClipDeliverySystem AUDI:08717648226366 FSCAIdentifier:MitraClipXTRMay1,2019 Stupefaction:AdvisoryRegardingtheUseoftheDevice Attention:ImplantingPhysician DearValuedAbbottCustomer: AbbottisvoluntarilyissuingthisFieldSafetyNoticefortheMitraClipXTRClipDeliverySystem,

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How to fill out urgent field safety notice

01

Gather all necessary information related to the safety notice, including product details, affected batches, reason for issuing the notice, and recommended actions.

02

Clearly outline the urgency of the safety notice and the potential risks involved.

03

Draft a concise and informative communication that clearly explains the issue and provides instructions for recipients on how to proceed.

04

Ensure that all relevant stakeholders are informed and that the safety notice is disseminated promptly through appropriate channels.

05

Monitor the response to the safety notice and take appropriate follow-up actions as needed.

Who needs urgent field safety notice?

01

Manufacturers

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Regulatory authorities

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Customers

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What is urgent field safety notice?

An urgent field safety notice is a communication issued by manufacturers to inform users and healthcare professionals about risks associated with a medical device or product that may affect patient safety, often detailing necessary corrective actions.

Who is required to file urgent field safety notice?

Manufacturers of medical devices or products that pose a risk to patient safety are required to file an urgent field safety notice.

How to fill out urgent field safety notice?

To fill out an urgent field safety notice, the manufacturer needs to provide detailed information about the product, the nature of the risk, the actions to be taken, and how to report back to the manufacturer.

What is the purpose of urgent field safety notice?

The purpose of an urgent field safety notice is to protect patients and users by informing them about potential hazards and guiding them on corrective actions to mitigate risks associated with the use of a specific medical device or product.

What information must be reported on urgent field safety notice?

The information that must be reported includes the product details, description of the hazard, actions to be taken by users, and contact information for further inquiries.

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