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Device Problem
Insufficient Information (3190)
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Patient Problem
Reaction (2414)
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Event Type
Injury
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Event Description
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Received a scientific article, titled "outcomes following 385 consecutive implantations of omega-3 fatty acid coated mesh"; per the article, "intraperitoneal placement of mesh requires the presence of an adhesion barrier to minimize adhesions, pain, and infectious complications.Barrier options include monolayer and hybrid mesh products.A single surgeon's 5-year experience with mesh utilizing a biologic coating of omega-3 fatty acid is presented." per the article, one patient presented with skin reactions (idiopathic).
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Manufacturer Narrative
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A thorough investigation was not able to be performed as no product code, lot number, sample or additional information were provided.According to the paper, the complication profile of o3fa coated mesh is comparable to that reported for other meshes.O3fa use is associated with reasonable outcomes, excellent patient tolerance, and effective hernia repair.It is now the prosthetic of choice for intraperitoneal placement at our institution.
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Search Alerts/Recalls
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