A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.The event of foreign body reaction is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: patient device incompatability and foreign body reaction.
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