Customer Feedback & Complaint Handling

1. An event in which manufacturers have received or become aware of information that reasonably suggests that one of it's marketed devices may have caused or contributed to a death or serious injury requiring notification to a regulatory authority in accordance with country adverse event reporting requirements.

Reportable Event

Abnormal Use

Complaint

Issue

A reportable event refers to an occurrence where manufacturers have received or become aware of information that suggests that one of their marketed devices may have caused or contributed to a death or serious injury. This event requires notification to a regulatory authority as per the country's adverse event reporting requirements.

Explanation

A reportable event refers to an occurrence where manufacturers have received or become aware of information that suggests that one of their marketed devices may have caused or contributed to a death or serious injury. This event requires notification to a regulatory authority as per the country's adverse event reporting requirements.

2. While surfing your favorite social media site, you become aware of some feedback posted regarding an LSI product, you should:

Call the FDA

Notify the Regulatory Department

Share the post with friends, all publicity is good publicity

None of the above

When you come across feedback about an LSI product on social media, it is important to notify the Regulatory Department. This is because the Regulatory Department is responsible for handling any issues or concerns related to the product. By notifying them, they can investigate the feedback and take appropriate actions if necessary, such as addressing any potential safety or quality issues. Calling the FDA may not be necessary unless the feedback suggests a serious safety concern that requires immediate attention. Sharing the post with friends may not be the best course of action as it can potentially spread misinformation or harm the reputation of the company.

Explanation

When you come across feedback about an LSI product on social media, it is important to notify the Regulatory Department. This is because the Regulatory Department is responsible for handling any issues or concerns related to the product. By notifying them, they can investigate the feedback and take appropriate actions if necessary, such as addressing any potential safety or quality issues. Calling the FDA may not be necessary unless the feedback suggests a serious safety concern that requires immediate attention. Sharing the post with friends may not be the best course of action as it can potentially spread misinformation or harm the reputation of the company.

3. The _____ is the main contact for complaint handling. It is their responsibility to process and manage all feedback, issues, and complaints through the GAS system.

Sales Consultant

Surgical Device Engineer

Complaint Coordinator

President

The Complaint Coordinator is responsible for processing and managing all feedback, issues, and complaints through the GAS system. They are the main contact for complaint handling, ensuring that customer complaints are addressed and resolved effectively. Their role is crucial in maintaining customer satisfaction and improving the overall quality of the organization's products or services.

Explanation

The Complaint Coordinator is responsible for processing and managing all feedback, issues, and complaints through the GAS system. They are the main contact for complaint handling, ensuring that customer complaints are addressed and resolved effectively. Their role is crucial in maintaining customer satisfaction and improving the overall quality of the organization's products or services.

4. Feedback from a customer, positive or negative should be reported through the complaint module in GAS.

True

False

Feedback from customers, whether positive or negative, should be reported through the complaint module in GAS. This implies that the complaint module is the designated channel for customers to provide feedback, regardless of its nature. Therefore, the statement "True" indicates that reporting feedback through the complaint module in GAS is the correct approach.

Explanation

Feedback from customers, whether positive or negative, should be reported through the complaint module in GAS. This implies that the complaint module is the designated channel for customers to provide feedback, regardless of its nature. Therefore, the statement "True" indicates that reporting feedback through the complaint module in GAS is the correct approach.

5. Issues and complaints be submitted to LSI through:(Select all applicable answers)

Email

In Person

Phone

USPS mail

A Regulatory Agency

This question asks for the methods through which issues and complaints can be submitted to LSI. The correct answer includes all the applicable options, which are Email, In Person, Phone, USPS mail, and A Regulatory Agency. This means that LSI accepts issues and complaints through these channels, providing multiple avenues for individuals to voice their concerns.

Explanation

This question asks for the methods through which issues and complaints can be submitted to LSI. The correct answer includes all the applicable options, which are Email, In Person, Phone, USPS mail, and A Regulatory Agency. This means that LSI accepts issues and complaints through these channels, providing multiple avenues for individuals to voice their concerns.

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