Additional information was received on october 30, 2015.This issue was investigated by confirming the silicone trilaminate, the skin contact material, used in this lot of product was certified meeting the requirements of convatec.Confirming the lot of product was sterilization certified; and referencing summary of health data for dow corning® mg soft skin adhesive.All manufacturing, materials, and sterilization process were compliant to requirements.No previous investigations are available.After the detailed batch review, no discrepancies (including non-conformances/deviations) were found.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required, and the complaint will be closed.(b)(4).
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