H3, h6: the device, intended to be used in treatment, has been returned and evaluated.The returned carton confirmed that the expiration and lot details were missing, establishing a relationship with the reported event.The root cause remains undetermined.Further information requests for the lot number, contained on the inner pouches was not provided.Probable cause includes missed quality check, or a packaging printing error.A review of the associated batch manufacturing records could not be carried out as no batch/lot number was provided.A complaint history review found this to be an isolated event, at this time no further action is required.Smith + nephew will continue to monitor for any adverse trends relating to the reported allegation.
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