During the investigation, it was determined that the patient has a pertinent reported medical history of hypertension, hyperlipidemia, and tias.The adverse event happened due to the patient's condition and pre-existing medical history and it resulted in a minor injury.The patient was taken to the er where the wound was cleaned and closed with skin adhesive and the patient was diagnosed with syncope and discharged.The device marketed by vyaire did not malfunction.As the adverse event happened in a hospital and the minor injury was treated there, this complaint is proactively reported to the fda and is not seen as a serious injury.
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