It was reported that the patient allegedly experienced a reaction (redness on skin) from either the gel on the actual electrode or the adhesive around the electrode.The patient was taken to the hospital and an epipen was administered.Per the ifu for these electrodes, it states "some patients may experience skin irritation or hypersensitivity due to electrical stimulation or electrical conductive medium.The irritation can usually be reduced by moistening the skin, using an alternative conductive medium or electrode placement." it is unknown what caused the patient's reaction to the product.Djo was unable to perform an investigation on the electrodes used on the patient as they were disposed of by the treatment facility.The root cause of the reaction is unknown as it occurred again while a non djo electrode was used on the patient during the emergency room visit.The patient was treated and released to the parents after a few hours of observation.
|