Supplemental reports GCHS

While you are looking at the investigation results, it says:

"The SN is unknown; therefore, the device history record could not be performance."

With that information, Type of investigation codes in the SR should be:

• B14, B11, B01

• B11, B01

• B14, B11

• B14, B17

If you found some missing information in the initial MW, and this information was found prior the initial MW was sent. According to this information, H2 should be selected as:

• Correction

• Additional information

• Blank

• Device evaluation

For a supplemental report, G3 should correspond to:

• When the investigation has finished.

• When a new PAE was found.

• G3 most not be changed.

• G3 is the initial reporter's name, it's not necessary in a supplemental report.

It's a good practice to have downloaded the FDA code files.

• True

• False

You have seen all the information prior drafting the SR, there is not any new finding in the investigation results, it means the decision tree should be completed as:

• Selected the first 3 questions as "yes".

• Select the last 4 questions as "yes".

• Fill it up in the same manner as previous MDR reportable assessment.

• Do not touch it.

It is NOT necessary to add in H10:

New information: D9, D10

If it was provided a concomitant dive that was not reported on the initial MW and found after its submitting date.

• True

• False

During estimate it is mentioned that there is a new PAE found, with this information, select the applicable option.

• Device problem code should be upgraded.

• Findings codes should align with all the reportable malfunctions.

• The clinical code should be changed to some other code.

• The non reportable malfunctions should be coded too.