Based on the information provided, no conclusion can be made.As reported, the patient is scheduled for a revision procedure, should additional information be provided a supplemental mdr will be submitted.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in april 2008.
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As reported, the patient was implanted with a composix kugel hernia patch on (b)(6) 2009.The patient has experienced pain which worsened in (b)(6) 2022.As reported the patient underwent a ct scan where some erosion was noted, however the surgeon has stated it was not affecting the bowel at this time.As reported, the surgeon recommended a revision procedure which is scheduled for (b)(6) 2023.
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