Modifying AER Details

You can modify the details of adverse event reports (AER) such as final status, submission date, due date, and regulatory response based on the state of the AER.

This task shows you how to:

Before you begin: You must be a regulatory user.
See Also
Creating Adverse Event Reports

Modify AER Due Date

You can modify due dates of multiple AERs.

Before you begin:
  1. From the Adverse Event Reports page toolbar, click Edit All.
  2. Click in the Report Due field corresponding to the required AER, click to select the required date.

    You can select only today's date or a future date.

  3. Click Save.
    The modified dates are saved.
  4. Click View All to exit edit mode.

Modify AER Details

You can update the details of the AER such as final status, submitted date, and regulatory response based on the state of the AER.

Before you begin:
  1. From the Adverse Event Report Properties page, in the Basic tab toolbar, click Edit.
  2. Perform any of the following actions based on the state of the AER.
    • If the AER is in Create state, select or clear the Final check box, as required.
    • If the AER is in Submission Approval state, click displayed next to Submitted Date, and select the required date.
    • If the AER is in Submitted state, type the response obtained from the regulatory body in the Regulatory Response box.
  3. Click Done.
    The updated details are saved.

Modify MDR Additional Details

You can update additional information related to AERs of type MDR.

Before you begin:
  1. From the Additional Details tab toolbar, click Edit.
  2. Update the following details.
    Field NameDescription
    Mfr Report Number (Format : 10 digit FDA Registration Number-Year-No of Incidents Reported) Type the required report number.
    Date of Report Click to select the required date.
    Initial Reporter Also Sent to FDASelect Yes if the reporter sent information to FDA. Select No if the reporter did not send information to FDA. Select Unknown if information is unknown.
    Product CodeType the required product code.
    STN NumberType the required STN number.
    PMA/510 (k) NumberType the required PMA/510 (k) Number.
    Contact NameType the name of the contact person.
    Contact AddressType the address of the contact person.
    Contact Phone NumberType the phone number of the contact person.
    Site AddressType the site address.
    Report SourceSelect one of the following sources.
    • Company Representative
    • Consumer
    • Distributor
    • Foreign
    • Health Professional
    • Literature
    • Study
    • User Facility
    If action reported to FDA under 21 USC 360i(f), list correction/removal reporting numberType the FDA report number.
  3. Click Done.
    The updated details are saved.

Modify MDV Additional Details

You can update additional information related to AERs of type MDV.

Before you begin:
  1. From the Additional Details tab toolbar, click Edit.
  2. Update the following details.
    Field NameDescription
    Recipient(Name of NCA)Type the name of the recipient.
    Address of National Competent AuthorityType the address of National Competent Authority.
    Date of this reportClick to select the required date.
    Reference number assigned by NCAType the reference number assigned by National Competent Authority.
    Identify to what other NCA's this report was also sentType the names of NCAs to which this report was sent.
    Status of submitterSelect any of the following statuses.
    • Authorized Representative within EEA and Switzerland and Turkey
    • Manufacturer
    • Others
    ClassSelect a medical device class.
    • AIMD Active Implants
    • IVD Annex II List A
    • IVD Annex II List B
    • IVD General
    • MDD Class IIa IVD Devices for self-testing
    • MDD Class IIb
    • MDD Class III
    Notified Body (NB) ID-numberType the identification number of the notified body
    Expected date of next reportClick to select the required date.
    CommentsType additional information.
  3. Click Done.
    The updated details are saved.