During a retroactive review of past complaints for potential adverse events, conducted as a capa in response to a recent fda inspection, a reportable adverse event was discovered.A nurse from a (b)(6) year old male patient's doctor office contacted zoll to report that the patient had an allergic reaction to the electrodes.One of the electrodes had created a red swollen area that was oozing.The doctor instructed the patient to move the garment a little bit to the side so the electrodes would not be on the same red swollen spots.However, the same thing happened to the new area of skin where the electrodes were moved to.A patient service representative (psr) was sent to follow up with patient two days later.The psr stated that the patient's skin under the right electrode is breaking down.The patient's wife moved the electrode to a different spot and the skin under the new area then also started to break down.There was no follow up on the skin break down to see if it healed.
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