Notification form for incidents:

 

 

If you experience a reportable incident*, you have to fill a email form . Messages through another delivery path will not be accepted . 

Your report will be edited as soon as possible .

 

* An incident according to "§ 29 Medical device act or § 2 sec.1 Ordinance on Medical Devices Vigilance of Germany " is any malfunction, any failure or deterioration in the characteristics or performance of a medical device as well as any inaccuracy in the labelling or instructions for use which has led, or could have led, directly or indirectly, to the death or serious deterioration in the state of health of a patient or user or another person.

 

Reporter data:

company

Person to contact:

Street:

Zip code:

City:

Country:

phone no.:

E-mail:

 

Incident:

date of incident:

place of incident:

part-no.:

lot no / Serial no:

equipment used with product:

description of incident:

 

injury to persons?  yes / no

already reported to any other authorithy?  yes / no

 

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