Convatec in submitting this report as a result of remediation activities related to the fda 483 issued april 16 2014.Device listed in this report is used for treatment, not diagnosis.Any additional info received regarding this event after filing this report shall be filed on a supplemental mdr.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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