On (b)(6) 2015, (b)(6) (marketing manager) received a phone call from dr.(b)(6) (chiropractor in (b)(6)).He stated that in april he treated a patient on the back of the calf to relieve muscle cramping in the calf.Patient had jeans on during the treatment.He reported burning feeling during the treatment.The doctor rubbed on the area to dissipate sweat in the area and resumed the treatment.No additional discomfort was reported by the patient.The patient has diabetes and is a male, approximately (b)(6).He exercises regularly and is in generally good health, all according to the doctor.After returning home to (b)(6), the patient called and reported a penny size burn on the back of the calf.He had sought medical attention and has had intervention by a wound care specialist.The wound is now a dime size and is still not completely healed, as noted by the doctor during phone conversation.Dr.(b)(6) stated that he always treats patients over their clothing and has never had a problem.He does take care to make sure there is no metal in the treatment area.An le (manufacturer's quality systems associate) called dr.(b)(6) back on (b)(6) 2015 to get more information.He refused to send the device back to manufacturer's facility for evaluation.He also mentioned that he already tested the device on himself and no problem was found.So he decided to continue using the device for other patients and no complaint was made so far.
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