Details of suspected adverse device reaction(s): (...

Details of suspected adverse device reaction(s): (a) Full description of reaction(s) including body site and severity, as well as the criterion (or criteria) for regarding the report as serious. In addition to a description of the reported signs and symptoms, whenever possible, describe a specific diagnosis for the reaction. (b) Start date (and time) of onset of reaction. (c) Stop date (and time) or duration of reaction. (d) Setting (e.g., hospital, out-patient clinic, home, nursing home). 5. Outcome: (a) Information on recovery and any sequel; results of specific tests and/or treatment that may have been conducted. (b) For a fatal outcome, cause of death and a comment on its possible relationship to the suspected reaction; any post-mortem findings. (c) Other information: Anything relevant to facilitate assessment of the case, such as medical history including allergy, drug or alcohol abuse; family history; findings from special investigations etc.