1. Administrative Information

Date*

Classification: *
DeathUnexpected serious deterioration in healthAll other reportable events

2. Information about the reporter

Name*

Contact*

Adress*

Postal code / City*

Country*

Phone*

Fax

Email*

3. Information about the medical device

Trade name*

Model*

Catalogue number*

Serial number*

Lot Nr.*

Purchased on*

Supplied by*

Supplied on*

First time use*

First time reprocessed*

Qty of products affected*

4. Information about the incident

Date of incidence*

Detailed desription*

Where is the product now?*

User of the medical device at the time of the incident*
professional userPatientOther

Use of the medical device*
First applicationReuse of a disposable productReuse of a reusable medical deviceDefect / problem detected before applicationServiced or repaired medical deviceOther

5. Patient information

Short- and long-term consequences of the incident for the patient*

Gender (if relevant)
malefemaleother

Age of the patient at the time of the incident

Weight in kilograms (if relevant)

6. Health Facility Information

Name*

Contact person*

Adress*

ZIP / City*

Country*

Phone*

Fax

Email*

I hereby agree to the processing of my data and the Privacy Policy.