H3, h6: the device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the reported event or determine a root cause.Probable root causes are the materials used within the dressing.Our medical assessment concluded: based on the complaint details, which report the use of the wipes in combination with electrodes, we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.Although it was communicated, after a one time use the remove wipe was discontinued, it is unknown how the burn was treated.Therefore, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional relevant clinical information be provided, this complaint will be re-assessed.No further medical assessment is warranted at this time.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.A complaint history review found further instances of the reported event.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain details relating to harm.This investigation is now complete with no further action deemed necessary.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
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