Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Inflammation (1932); Pain (1994); Hernia (2240)
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Event Type
Injury
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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) 2008 and mesh was implanted.It was reported that the patient underwent revision surgery and recurrent hernia repair surgery on (b)(6) 2009 and mesh was implanted during which the surgeon noted adhesions to the omentum and a dense adhesion to the hernia sac.It was reported that the patient underwent revision surgery on (b)(6) 2011 during which the surgeon noted dense adhesions between the small bowel and the mesh and damage to part of the small bowel, requiring the need for a bowel resection.It was reported that the patient underwent revision surgery on (b)(6) 2012 during which the surgeon noted part of the small intestine had come through the mesh and stuck to the fascia and significant adhesions.It was reported that the patient experienced severe pain and inflammation.Other procedure is captured under separate file.No additional information was provided.
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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.(b)(4) submitted for adverse event which occurred on (b)(6) 2009.(b)(4) submitted for adverse event which occurred on (b)(6) 2011.(b)(4) submitted for adverse event which occurred on (b)(6) 2012.
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Manufacturer Narrative
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Date sent to the fda: 7/14/2022.
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Manufacturer Narrative
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Date sent to the fda: 8/2/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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