Reporting Form

Incident / Near incident to get an emergency number

1. Administrative Information

Date of report

Classification of the incident

2. Personal details of the reporting person

Name

First

Last

Contact person

E-Mail-Adresse

Phone

Fax

Street, No.

Postcode

City

Country

3. Information on the medical device

Trade name / Product name

Model number

Catalog number

Serial number(s)

Lot Nr.

Date of purchase

Delivered by

Date of delivery

Date of first use

Date of first preparation

Number of products concerned

4. Information on the incident

Date of incident

Detailed description of the incident

Where is the medical device at the moment?

User of the medical device when incident occurred

Date of Trade

Kind of use of the medical device

5. Patient details

Short- and long-term effects of the incident on the patient

Gender (where relevant)

Patient’s age when incident occurred

Weight in kg (where relevant)

6. Information on health facility

Name of health facility

Kontaktperson in the health facility

Email Adress of the health facility

Phone of the health facility

Fax of the health facility

Street, No. (health facility)

Postcode (health facility)

City (health facility)

Country (health facility)