Incidentis defined (§ 29 German Law of Medical Devices or § 2 para. 1 German MPSV) as any malfunction, failure or deterioration in the characteristics or performance of a medical device as like any improper labeling and/or improper instructions for use that directly or indirectly to death or to a serious deterioration in health of a patient or user or any other person (third) has resulted or could have resulted (incident).
For more information please check the European Guidance for reportable events MEDDEV 2.12/1 rev.8.
If an adverse event has been detected, please fill out LAWTON Incident Report form and transmit it to
adverse.event@lawton.de.
We will proceed any incident as soon as possible.