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Medical device adverse incident report form Breast implants surgeons Reporter details Name: Position/occupation: Organization: Address: Tel: Email: Consultant-in-charge (if known): This report confirms:
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What is medical device adverse incident?
A medical device adverse incident refers to any untoward event or undesirable occurrence involving a medical device, which may cause harm or have the potential to cause harm to a patient, user, or any other person.
Who is required to file medical device adverse incident?
Manufacturers, importers, and distributors of medical devices are required to file medical device adverse incidents.
How to fill out medical device adverse incident?
Medical device adverse incidents can be reported by filling out the appropriate incident report form with detailed information about the incident, including the device involved, the nature of the incident, and any resulting harm or potential harm to patients or users.
What is the purpose of medical device adverse incident?
The purpose of reporting medical device adverse incidents is to ensure patient safety and to monitor the performance and safety of medical devices in the market. It helps regulatory authorities to identify and address potential risks associated with medical devices.
What information must be reported on medical device adverse incident?
The information to be reported on a medical device adverse incident includes the device identification details, description of the incident, the harm or potential harm caused, information about the patient or user affected, and any actions taken in response to the incident.
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