Adverse event reporting and harms {22}
motor, deficits
ADVERSE EVENT, ADVERSE EVENTS, ADVERSE EVENT, EVENT, ADVERSE EVENT
Adverse events will be collected, reported and assessed using standardized procedures in accordance with the regulatory requirements. The management and reporting of adverse events is supervised by the Pharmacovigilance Department at the Clinical Trials Center (ZKS Tübingen). For the purpose of this trial, the period of observation for collection of adverse events extends from the first use of the device until 7 days after the last application of the device. Any deterioration in the state of consciousness or neurological, especially motor, deficits will be recorded during the study. The assessment of the severity of the event is in accordance to the Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0). The relationship between the use of the medical device and the occurrence of each adverse event will be assessed for causality and categorized by the sponsor investigator and the second assessor.