This medwatch report is a result of a retrospective investigation of customer complaints and has been deemed reportable due to insufficient patient information.Based upon the information that breas presently possesses, it is unable to confirm whether the event is reportable under the standard set forth in the applicable fda regulations and guidance.Accordingly, in an abundance of caution, breas is filing a medwatch report for this event.Being part of a retrospective analysis, this report is submitted later than 30 days after the initial date on which breas became aware of the event, as has previously been discussed with the fda.
|