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This document is an urgent notification from SONEWA GmbH concerning a recall of STYLAGE M lidocaine, batch number 232281101. It details a potential issue where a syringe of STYLAGE XL lidocaine was

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How to fill out urgent field safety notice

01

Identify the medical device or product that requires the urgent field safety notice.

02

Gather relevant details such as the model number, serial numbers, and batch information.

03

Clearly describe the safety issue, including potential risks to patients or users.

04

Specify the actions that need to be taken by recipients, such as discontinuing use or returning the product.

05

Provide contact information for further questions or support.

06

Ensure the notice is dated and includes a reference number for tracking.

07

Distribute the notice to all affected parties, including healthcare facilities and patients as necessary.

Who needs urgent field safety notice?

01

Healthcare professionals and providers who use the affected medical device.

02

Patients who may be impacted by the safety issue.

03

Regulatory authorities responsible for monitoring medical device safety.

04

Manufacturer representatives for addressing the safety issue.

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What is urgent field safety notice?

An urgent field safety notice is a communication issued by manufacturers or regulatory authorities to inform healthcare professionals and patients about medical device safety concerns that require immediate attention.

Who is required to file urgent field safety notice?

Manufacturers of medical devices and relevant regulatory authorities are required to file urgent field safety notices when safety issues arise that could impact patient health or device performance.

How to fill out urgent field safety notice?

To fill out an urgent field safety notice, stakeholders must include information about the device, the nature of the issue, recommended actions for users, and instructions for reporting adverse events or complications.

What is the purpose of urgent field safety notice?

The purpose of an urgent field safety notice is to alert healthcare providers and patients about potential risks associated with a medical device and to ensure appropriate corrective actions are taken to mitigate those risks.

What information must be reported on urgent field safety notice?

The information that must be reported includes device identification details, description of the safety issue, advised actions to users, and contact information for the manufacturer or authority responsible for the notice.

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