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Home » FDA Inspection Shows Fisher Wallace Failed to Report Serious Adverse Events
FDA Inspection Shows Fisher Wallace Failed to Report Serious Adverse Events
Despite customers’ reporting symptoms that included stroke, memory loss, atrial fibrillation, bradycardia and seizures after using Fisher Wallace Labs’ at-home cranial electrotherapy stimulator (CES) 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.
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