H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found the label in question is fraudulent.This label was not printed from any s+n global labeling controlled systems.A labeling expert certified multiple inconsistencies.The customer provided image and video display the fraudulent label.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.A review of the packaging specification found the carton label is product specific to the bill of materials.The complaint was confirmed and the root cause was associated with a falsified device.No containment or corrective actions are recommended at this time.
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