Summary Report

This page displays details of the complaint including contact information, events, products, and product evaluation information.

Important: This app creates reports or generates content that contains personal data. Manage these in accordance with good personal data treatment practices.

To access this page:

From the Complaint Properties page, in the Properties tab toolbar, select Actions > Summary Report.

This topic describes:

This page discusses:

Fields
Events

Fields

Complaint


Section Name	Field Name	Description
Basic Information	Name	Name of the complaint
	Owner	Name of the complaint owner
	Originator	Name of the complaint originator
	Receipt Date	Date when the complaint was raised
	Modification Date	Date when the complaint was last modified
	Date of Awareness	Date when the problem was identified
	Distributor Awareness Date	Date when the problem was identified by the distributor
	Status	State of the complaint. Possible states are Create, In Process, and Closed.
	Source	Communication method through which the complaint was raised
	Customer Severity	Severity level of the complaint
	Country Of Origin	Country in which the problem was identified
	Additional Information	Additional information about the complaint
	Purchase Order	Purchase order number related to the product
	Complaint Handling Unit	Name of the company that handles the complaint
	Reassign Rationale	Reason provided when the complaint was reassigned
	Type Change Justification	Reason provided when the complaint was converted from an equipment service request or inquiry
Invalidation Details	Invalidator	Name of the invalidator
	Invalidated Date	Date when the complaint was invalidated
	Invalid Rationale	Reason provided when the complaint was invalidated
Closure Details	Customer Closure Date	Date when the complaint was closed by customer
	Date Closed	Date when the complaint was closed
	Closed Rationale	Reason provided when the complaint was closed
Reopen Details	Count	Number of times the complaint was reopened
Reopen Details	Reopen Rationale	Reason provided when the complaint was reopened

Contacts


Section Name	Field Name	Description
Contact	Salutation	Formal salutation when addressing the contact
	First Name	Person's first name
	Last Name	Person's last name
	Title	Person's job title
	Business/Agency	Company in which this person works
	Contact Type	One of the following types of contacts: Company Representative Consumer Customer Distributor Manufacturer Reporter User Facility
	Occupation	Person's job function
Address	Address Line 1	Person's mailing address
	Address Line 2	Additional address information
	City	City
	State	State
	Country	Country
	ZIP/Postal Code	Zip or other postal code
Phone Numbers	Home	Person's home number
	Mobile	Person's cell phone number
	Work	Person's work number
	Email Address	Person's e-mail address

Events


Column Name	Description
Experience Code	Experience code, which is used to classify the problem
Originator	Name of event creator
Owner	Name of event owner
Primary	Yes: event is primary No: event is not primary
Event Confirmed	Yes: event is confirmed No: event is not confirmed
Date of Occurrence	Date on which the problem occurred
Receipt Date	Date on which the problem was reported
Issue Code	Issue code, which is used to classify the issue
Event Confirmed Date	Date on which event was confirmed
Timing	Process during which the problem was identified. Shows FDA codes for timing. Possible values are: Kit Inspection Other Unknown Upon Receipt
Event Detail	Description of the problem
Files Attached	Names of attached files

Products


Column Name	Description
Name	Name of the model
Revision	Revision number of the model
Type	Type of the object, model
Marketing Name	Marketing name of the product model
Model Number	Model number of the product model
Batch/Lot Number	Batch number of the model
Serial Number	Serial number of the model
Expiration Date	Expiration date of the model
Device In Use	Yes: device was in use when problem occurred No: device was not in use when problem occurred
Device Quantity	Quantity of product model used
Unit of Measure	Unit of measure of the quantity

Product Evaluation Details


Section Name	Field Name	Description
	Investigation Required	Yes: evaluation is required No: evaluation is not required
	Severity	Severity of the evaluation. Possible values are High, Low, Medium, and Urgent.
	Location	Name of the location where the evaluation was performed
	Rationale	Reason provided by the investigator to select the conclusion code
	Method	evaluation method code
	Results	evaluation result code
	Conclusion Code	evaluation conclusion code
Approval Sign-off	Responsible Investigator	Name of the investigator
Approval Sign-off	Date	Date when the evaluation was completed
Risk Analysis	Risk Analysis Required	Yes: risk analysis is required No: risk analysis is not required
Risk Analysis	Comments	Reason provided by the investigator about the risk analysis requirement
Conclusion	Malfunction	Yes: problem occurred due to product model malfunction No: problem did not occur due to product model malfunction
	Packaging / Labeling Problem	Yes: problem occurred due to packaging or labeling issue No: problem did not occur due to packaging or labeling issue
	Use Error	Yes: problem occurred due to wrong usage No: problem did not occur due to wrong usage
	Summary Details	Summary of the evaluation

Adverse Event Reports


Field Name	Description
Name	Name of the adverse event report (AER)
AER Type	Type of AER. Possible values are MDR, CMDR, MDV, and PMDA.
Revision	Revision number of AER
Status	Status of the AER
Final	True: AER is final False: AER is not final
Classification	AER classification based on type
Reviewed Date	Date on which AER was reviewed
Submitted Date	Date on which AER was submitted

Tasks


Field Name	Description
Name	Name of the task
Title	Title of the task
Status	State of the task
Due Date	Scheduled completion date of the task
Assignee	Name of person to whom task is assigned
Instructions	Route instructions

Correspondence


Field Name	Description
Communicator	Name of person who started the correspondence
Date	Date on which correspondence was started
Method	Correspondence method
Source	Correspondence source
Comments	Comments from the correspondence

Where Used


Field Name	Description
Name	Name of object related to the complaint
Type	Type of object related to the complaint
State	State of object related to the complaint
Owner	Owner of object related to the complaint
Description	Description of the related object