Medical device current location/disposition: the patient is still using the device.Patient outcome: patient has made a full recovery.Remedial action taken by the healthcare facility relevant to the care of the patient: following the incident mr (b)(6) decided to visit his physiotherapist to get some pain relief; however, there was no significant improvement in his condition.Mr (b)(6) then visited his gp who referred him for an ultrasound examination which came back negative.After the examination, mr (b)(6)reported losing the ability to walk on the heel of his right foot making walking difficult.Mr (b)(6) then made an appointment with his rheumatologist (dr.(b)(6)) on the (b)(6) 2017 who diagnosed an elongation of the peroneal nerve.Dr.(b)(6) prescribed 12 physiotherapy sessions with massage and electrostimulation of the right peroneal nerve.Further advice was provided by mr (b)(6)'s angiologist who advised him to only use the device again after initial warm up exercises.
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Please note: following an fda inspection at actegy ltd between march 5-8, 2018 by mr (b)(6), it was identified this incident should have been reported to fda.Therefore, the following incident is being reported retrospectively: mr (b)(6) reported pains in legs and calves and stated that he was not able to walk following use of the device and that he no longer had control of muscles controlling his ankle.Doppler ultrasound confirmed no circulation related cause.Hospital rheumatologist has prescribed physiotherapy and the customer is no longer experiencing any problems and existing medical conditions are still to be confirmed.
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