Samples received: none.Analysis and results: there are no previous complaints of this code batch.(b)(4) units of this product were manufactured and distributed in the market, there are no units in stock.Reviewed the batch manufacturing record this product had a normal process and the results during the process fulfills the oem requirements.There is a deviation prior to the release of the product, it was related to the ampoules, they were approved.Remarks: as indicated in the histoacryl flexible instructions for use: "closure of minimum-tension skin wounds from clean surgical incisions and simple, thoroughly cleansed, trauma-induced lacerations." "hold the edges together for approximately 30 seconds after application to allow histoacryl flexible to cure and to prevent displacement of the wound edges." final conclusion: complaint is not justified.Although the results of the samples received fulfills the oem requirements, note is taken of this incidence in order to assess if new or additional actions are needed.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.
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