Introduction

Advantus Product Compliance is located in Jacksonville, Florida.  It is the designated unit for review, evaluation, and maintenance of customer feedback and compliant files for Advantus. 

Manufacturers and importers of medical devices are required to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints. Importers are also subject to complaint files because “initial distributors of foreign entities” fall under the definition of a manufacturer in 21 CFR 820.3.

The manufacturer, packer, or distributor whose name appears on the label of an OTC drug (i.e hand sanitizer) marketed in the United States without an approved application must submit to FDA any report received of a serious adverse event associated with such drug when used in the United States.  The “responsible person” is the manufacturer, packer, or distributor whose name (under section 502(b)(1) of the Act) appears on the label of an OTC drug marketed in the United States.

All product complaints including MDR and non-MDR events must be forwarded to the manufacturer.

Complaint files that are found to be reportable MDR events should be maintained in a separate portion of the complaint file or otherwise clearly identified.

Important Terms:

Process Overview

Advantus Compliance department is responsible for establishing a Formally Designated Complaint Unit to handle customer feedback and product complaints, including timely and uniform receipt, review, and evaluation.  Requirements are the responsibility of Compliance.  Advantus employees are required to maintain and reinforce consumer and/or patient privacy regulations throughout the customer feedback and complaint handling process.

Customer Feedback

Medical Device and OTC Drug Customer Feedback and Product Complaints can be received through multiple sources (phone calls, email, sales calls, trade shows).  The following types of examples are customer feedback:

• Product information/Warranty inquiries
• Cosmetic comments (color, size, and shape preferences)

Obtain and record the following information from the source:

• The name of the device or OTC drug
• The date information was received
• Product Identifier (Name/Item #/Model number)
• Name, contact information of reporter
• Nature of details of feedback or issue
• user/patient/consumer outcome of any reported issue
• if applicable, detail of any undesirable health consequence

Generate Customer Feedback Record

Upon receipt of customer feedback, Compliance creates a Customer Report/Feedback record and ensure each event has only one associated complaint record.  There may be multiple sources of customer feedback regarding a single event and user and these must be merged into one record.  Include all known information.

Arranging a return for product analysis:

• UPS account : A36W25  
• Mark on the invoice showing sample without commercial value, and the value to make $5

Company name: Shenzhen Jiacom Technology Co Ltd.

Address:301, No.598-4, Dahe Village, Guancheng Community,

Guanhu Street, Longhua District, Shenzhen, Guangdong, China

Contact name: Kiki Liu

Phone:008613149931033/008675529015600

Intake, Assessment, and Complaint Determination

All customer feedback received must be reviewed by Compliance.  Compliance will complete the following:

• Perform review for minimum information/event details.  Ensure event narrative is clear.  Determine the correct amount of records and quantity is recorded.  Medical Device Customer Feedback and Product Complaints can be received through multiple sources.  Therefore, multiple reports for a single event may be received at different times.
• Make complaint determination and complete fields accordingly.
• For all models of  (FR800, FR8400) Non-contact thermometers,  send a copy of the initial Customer Report/Feedback record to zhongjingming@szjiakang.com.

Assess Customer Feedback Record

1. Evaluate each record and determine if the event constitutes a complaint.
2. Evaluate each record and determine if an Adverse Event is reported.
3. Make requests for additional information regarding the event and product as necessary.  Document all requests as part of the customer report/feedback record.
4. Evaluate new information obtained to determine if the new information impacts any previous decisions.  Send additional information to the factory.
5. Evaluate the report for any adverse events or alleged product malfunctions that may lead to serious injury or death.  Determine if these events are reportable to the regulatory agency.

A decision not to investigate, supported by written rationale—including the name and signature of the individual making the decision not to investigate—must be retained in the customer feedback/report file.

Customer Communication/Vendor Communication

Document notes of all external communication.

Record Completion/Closure

When the Customer Report/Feedback record is complete, provide a copy of the completed record to the factory.

• For all models of  (FR800, FR8400) Non-contact thermometers: email zhongjingming@szjiakang.com.

Maintain records to be accessible to the factory and auditors should need to arise.

Monitoring of Customer Report/Feedback records

Compliance will monitor frequency, type, as well as evaluate timeliness measures on a periodic and ongoing basis.

Medical Device Reporting (MDR) (21 CFR 803)

Manufacturers and importers are required to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints. Importers are also subject to complaint files because “initial distributors of foreign entities” fall under the definition of a manufacturer in 21 CFR 820.3.

• Manufacturers are responsible for the following:
  • Submitting reportable events to the FDA.  If there is an incident of death or serious injury, or if the device malfunctioned in a manner that could contribute to death or serious injury if it were to recur, it must be reported to the FDA.

Adverse Event Reporting

Healthcare professionals, consumers, and manufacturers submit reports to FAERS. FDA receives voluntary reports directly from healthcare professionals (such as physicians, pharmacists, nurses, and others) and consumers (such as patients, family members, lawyers, and others). Healthcare professionals and consumers may also report to the products’ manufacturers. If a manufacturer receives a report from a healthcare professional or consumer, it is required to send the report to FDA as specified by regulations.

The FDA Adverse Events Reporting System (FAERS) Electronic Submissions website provides drug and therapeutic biological product manufacturers, distributors, packers, and other interested parties with information about FDA Adverse Event Reporting System (FAERS) electronic submissions and instructions on how to electronically submit post-marketing individual case safety reports (ICSRs), with and without attachments.