Adverse Consequences
Was a death or serious injury sustained by the patient/user?
Was a death or serious injury only avoided due to medical or surgical intervention?
When did the adverse consequence occur?
During a treatment, during a follow up appointment, while cleaning the device, etc
Where did the adverse consequence occur?
In the treatment area, in a storage area, etc
Who was impacted by the adverse consequence?
Patient, user, bystander, etc
Please describe the adverse consequences, include as much detail as possible.
Please list the UDI or serial numbers of all probes and/or control unit(s) involved.