Users Medical Device Incident Report

Are you a medical device user?*

Please provide your name and at least one contact method

Title:

First name: (*)

Surname:(*)

Email:

Telephone:

Please confirm your contact and privacy instructions

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

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

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

What went wrong?

When did the incident occur? (*)

Date of initial procedure

Select the date by clicking in the box above

How many times has this occurred? (*)

Type something.

Provide a description of what went wrong: (*)

Where did the incident occur?

At what Organization / Facility / Location?

Adress:

Town:

Country:

Postcode:

Has the supplier been told about the problem?

Please specify if the supplier has been told about the problem?

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 sex:

Their weight (Kg):

Their age (Years, Months):

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:

Batch Number:

Expiry date:

Who supplied the device?

Where did the device come from? *

Purchased / Supply date:

Supplier Name:

Accessing the device for inspection / testing

Where is the device now?

Submit Report