Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Stenosis (2263); 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 bilateral hernia repair surgery on (b)(6) 2008 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2020 during which the surgeon noted chronically infected tissue along with a fistula to the mesh graft.Pus was seen coming from the mesh and the mesh was found to be densely adherent to multiple loops of small bowel.There was a segment of the small bowel which was severely stenotic and obstructed.A small bowel resection was performed.There was also a finding of an abdominal abscess secondary to the infected mesh.It was reported that the patient experienced severe pain and inflammation.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 12/1/2021.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: 3/3/2022.
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Search Alerts/Recalls
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