Somatics became aware of this event on the maude website in early april.The patient submitted medwatch report provided by fda.It referenced the event date of (b)(6) 2017.It does not provide any contact information for the treating physician or facility, nor any additional information about the circumstances surrounding the reported event.The report also does not provide any laboratory results or other objective information to corroborate the complainant's description of the adverse effects suffered in relation to electroconvulsive therapy.Somatics sent a return receipt letter requesting documentation of the missing information above.When received back, somatics will update this report if it is deemed warranted.
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