FDA Inspection Shows Fisher Wallace Failed to Report Serious Adverse Events

Despite customers’ reporting symptoms that included stroke, memory loss, atrial ffibrillation, bradycardia and seizures after using Fisher Wallace Labs’ at-home electroconvulsive therapy (ECT) device, the company did not submit the required Medical Device Reporting within 30 days to let the FDA know that serious adverse events (SAE) had occurred.
Source: Drug Industry Daily