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 causes are application, removal, time left on patient, trauma, materials used within the dressing.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional rmr is not required.Therefore, based on insufficient information it cannot be definitively concluded that the root cause of the reported rash is the direct result of using the allevyn dressing.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.No batch/lot number has been provided, therefore a review of the device history has not been possible.The complaint history file contains further instances.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.
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