User Feedback Form

1.1 Name of organization

1.2 Street name and no

1.3 City and postcode

1.4 Country

1.5 Name of contact person (for organization)

1.6 Mobile telephone of contact person (for organization)

1.7 Position of contact person (for organization)

1.8 E-mail of contact person (for organization)

1.9 Report date

2.1 Product name/commercial name/brand name

2.2 Model number(s)

2.3 Lot number/batch number(s)

2.4 Expiry date(s)

2.5 Authorized representative name

2.6 Authorized representative contact details (e-mail)

2.7 Please attach a copy of the instructions for use and photographs of the device and its labelling

3.1 Describe the clinical/analytical procedure during which the observation was made (note: in the case of IVD, state specimen type used)

3.2 Event description (e.g. in the event of negative feedback, explain what went wrong with the medical device, and what was the health impact [death, life-threatening, indirect harm such as misdiagnosis or delayed diagnosis/treatment], and in the event of positive feedback, explain suggestions for improvement or positive experiences)

3.3 Number of devices involved: Number of patients involved

3.4 Operator/user at the time of the observation/event (please choose)[Choose at least 1 item]

3.5 Has more than one user had the observation with the product?  

3.6 Date of report

3.7 Signature