User Feedback Form

1.Contact details of the reporting user (organization/person)
* 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.Product details
* 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.Event details
* 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 items】
* 3.5 Has more than one user had the observation with the product?  
* 3.6 Date of report
* 3.7 Signature
Disclaimer: The act of reporting an observation is not an admission of manufacturer, user or patient liability for the event or its consequences.