Based on the available information, this event is deemed a reportable malfunction.No further information was available at the time of the report.No lot number or complaint sample was available for evaluation.A detailed investigation or batch review could not be conducted.Therefore, this evaluation will be closed and will be monitored through our post market product monitoring review process.Should additional information become available, a follow-up report will be submitted.Note: two cases associated with this complaint.A separate 3500a form has been completed to for the other case.Reported to the fda on december 23, 2015 (b)(4).
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