Medwatch sent to fda on 1/5/2016.Further information from the reporter regarding event, product, and patient details has been requested.No additional information is available at this time.The event of "exposure" 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.These events are being reported because medical intervention was required, although device-relatedness has not been established.
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