Convatec is submitting this report as a result of remediation activities related to the fda 483 issues april 16, 2014.Device (s) listed in this report is (are) used for treatment, no 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 may 2011.The data presented is from three different product applications.The report states that there are no significant trends.Brand name: s4s/sur-fit durahesive moldable convex skin barrier w/ flange w/ white tape collar and mold-to-fit opening (overall dimension 4.5" x 4.5").
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