Catalog Number PHY1015V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Obstruction/Occlusion (2422)
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Event Type
Injury
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Manufacturer Narrative
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To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
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Event Description
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2014 and mesh was implanted.It was reported that the patient underwent surgery on (b)(6) 2017 during which the surgeon noted extensive adhesions to the site of the previously placed mesh and performed extensive adhesiolysis to free the bowel and omentum from the mesh and rectify the bowel obstruction.It was reported that the patient experienced severe chronic pain, small bowel obstruction, scarring, anxiety and stress.It was reported that the patient had a mesh implanted on (b)(6) 2006 and underwent removal surgery on (b)(6) 2006 during which the surgeon noted mesh migrated and evulsed from the prior repair site, with bowel and adhesions entrapped within the mesh which is captured in a separate file.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 7/3/2022 additional information: d4, h4 a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Manufacturer Narrative
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Date sent to the fda: 10/28/2022.
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Search Alerts/Recalls
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