Convatec is submitting this report as a result of remediation activities related to the fda 482 issued april 16, 2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.Activelife convex 1-piece pre-cut drainable pouch w/durahesive skin barrier w/1-sided comfort panel and tape collar 12" transparent.Analysis is taken from a trending report of evaluations or adverse events finalized (b)(6) 2011.The data presented is from three different product applications.The report states that there are no significant trends.
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