Notification Form
Incident / Near-Incident
to receive an emergency telephone number

1. Administrative Information

Date of notification*
Incident classification *

2. Information on the reporting person

Name *
Contact person*
Address*
Postal Code / City*
Country*
Telephone*
Fax
E-Mail*

3. Information on the medical device

Commercial name/Product name*
Article number*
Catalogue number*
Serial number(s)*
Lot No. *
Purchased on *
Delivered by*
Delivered on
Initial use
Initial re-processing
Number of products concerned*

4. Information on the incident

Date the incident occured*
Detailed incident description*
Current location of the medical device*
User of the medical device at the time of incident *
Use of the medical device *

5. Information on the patient

Short-term and long-term consequences
of the incident for the patient*
Gender (if relevant)
Age of patient at time of incident
Weight in kgs (if relevant)

6. Information on the healthcare facility

Name *
Contact person*
Address*
Postal Code / City*
Country*
Telephone*
Fax
E-Mail*


 


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