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The FDA reviewed Medical Device Reports (MDRs) and literature reports which describe adverse events, such as neurological deficits (e.g., focal motor deficits, aphasia, cognitive changes), increased intracerebral edema or pressure, intracranial bleeding, and/or visual changes (e.g., visual field deficits, blurry vision) when these devices were used to treat intra-cranial lesions

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Compromised Health : Balancing the need for Vitamin B12 with the risk of allergic reactions requires careful management and often medical supervision