File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.A clinical investigation was performed.The customer states a new diagnosis of asthma, non productive cough, bronchitis, and wheezing.She has an extensive medical background including but not limited to neurological damage from a car accident.The customer was not willing to provide/conclude a full clinical investigation and disconnected our call.Therefore, i was unable to gather pertinent information regarding her use of the soclean.In addition to an inconclusive clinical investigation the customer declined to return the soclean unit.It is not unreasonable to assume that the customer's experience/injury is not directly correlated to the soclean usage.She has seen the md with what she states to be asthma from an unknown cause/source.Reporting for due diligence.
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The customer states a new diagnosis of asthma, non productive cough, bronchitis, and wheezing.She has seen the md with what she states to be asthma from an unknown cause/source.The customer received a nebulizer and inhaler.It is important to note that after discontinued use of the soclean the customer was still experiencing bronchitis and has an extensive history of preexisting medical conditions.Reporting for due diligence.
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