(b)(4).Manufacturing site evaluation: samples received: 1 unopened pouch.Analysis and results: there are no previous complaints of this code-batch.Manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in stock.Thread surface on the closed sample received is the current and the usual one, no defects have been found.On the other hand, sewing test on artificial skin tissue has been conducted with the sample received and the thread slips correctly through the tissue.Moreover, the stitches have been removed from the tissue without difficulty.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill the oem requirements.Final conclusion: although the results of the samples received fulfill the oem specifications, note of this incident is taken 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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Country of complaint: (b)(6).It was reported that after sutures, thyroid - the day after a surgery; hernia - 7th day after a surgery.In one case, the suture was removed - it was very painful for a patient.All med watch submissions related to this report are: 3003639970-2018-00173, 3003639970-2018-00204, 3003639970-2018-00205.
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