Users Medical Device Incident Report

Are you a medical device CE product user? (*)

Select option.

Please provide your name and at least one contact method

First name (*)

Your first name

Surname (*)

Your surname

Phone

Email

Please confirm your contact and privacy instructions

Do you agree Galaxa Pharma /CANNORDIC to contact you about this incident?

Select option.

If no to above question, please provide details of a person who could be contacted instead of you regarding this incident:

Enter email address.

Are you reporting this incident on behalf of someone else (the initial reporter)?

Select option.

What went wrong?

When did the incident occur? (*)

Please select date

Date of initial procedure

Please select date

How many times has this occurred? (*)

Enter number

Provide a description of what went wrong: (*)

Enter description

Where did the incident occur?

At what Organization / Facility / Location?

Enter name of place

Has the supplier been told about the problem?

Please specify if the supplier has been told about the problem

Select option.

Background information

Please note that you don’t have to fill in these fields below if you don’t have the information or would rather not report it.

The affected person's gender:

Their weight (Kg):

Their age

Describe the health consequences

Injured – extent of injury:

Device identification

Try to provide as much information as possible to help identify the device, including additional details such as model, version etc. if relevant and available. Ensure that the device is quarantined with all consumables and packaging.

Brand / Trade name

Product name

Batch number

UDI for the product

Expiry date

Please select date

Who supplied the device?

Where did the device come from?

Purchased / Supply date

Please select date

Supplier name

Accesing the device for inspection/testing?

Where did the device come from?

SUBMIT REPORT

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Users Medical Device Incident Report

Address

Phone

Follow Us

Please provide your name and at least one contact method

Please confirm your contact and privacy instructions

What went wrong?

Where did the incident occur?

Has the supplier been told about the problem?

Background information

Describe the health consequences

Device identification

Who supplied the device?

Accesing the device for inspection/testing?

Thank you!