Medwatch sent to fda on 01/19/2016.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The event of infection is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.The device has not been returned.Therefore, no analysis or testing has been done.Device labeling addresses the reported event of infection as follows: "adverse reactions are those typically associated with surgically implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion." these events are being reported because medical intervention was required, although device-relatedness has not been established.
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