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URGENT MEDICAL DEVICE FIELD SAFETY CORRECTIVE ACTION CONTRAINDICATION FOR THORACIC USE Duet TRS Loading Units January 13th, 2012 Attention: Risk Management Director and O. R Materials Management to

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What is urgent medical device field?

The urgent medical device field refers to a specific section or category in medical device reporting that identifies devices that require immediate attention or action due to safety concerns arise.

Who is required to file urgent medical device field?

Medical device manufacturers, importers, and distributors are required to file the urgent medical device field if they become aware of any information indicating a device may have caused or contributed to a serious injury or death.

How to fill out urgent medical device field?

To fill out the urgent medical device field, the relevant information regarding the device, the adverse event, and any known or suspected causes must be documented accurately. This typically includes details such as device description, patient information, date of event, and a description of the event itself.

What is the purpose of urgent medical device field?

The purpose of the urgent medical device field is to ensure timely reporting of incidents involving medical devices that may pose a risk to patient safety. It allows regulatory authorities to quickly identify and address potential issues with these devices in order to protect public health.

What information must be reported on urgent medical device field?

The urgent medical device field should include information such as the name and contact details of the reporting entity, the device identification details, a description of the adverse event or problem, any available patient injury information, and any actions taken to address the issue.

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