Model Number PCDN1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Inflammation (1932); Pain (1994); Perforation (2001); Septic Shock (2068); Peritonitis (2252); Renal Impairment (4499)
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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.(b)(4) submitted for the adverse event which occurred on (b)(6) 2019.(b)(4) submitted for the adverse event which occurred on (b)(6) 2019.
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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) 2009 and mesh was implanted.It was reported that the patient underwent an appendectomy on (b)(6) 2019 during which the surgeon noted ¿the small bowel and omentum had adhered to the underside of the previously placed midline umbilical mesh.The patient was in septic shock with acute kidney failure secondary to bowel perforation that was possibly caused because of the dense intraabdominal adhesions to prior mesh and tacts.¿ an open surgery was performed on (b)(6) 2019 during which the surgeon noted ¿multiple loops of small bowel and omentum were found densely adhered and tethered to the 10 cm previous underlaid midline round mesh.He dissected free the adhesions and resected approximately 30 cm segment of the injured small bowel.Due to the inflamed peritonitis and serositis, he irrigated the abdominal wound, placed vacuum assisted drainage and left the wound opened.¿ the patient underwent removal surgery on (b)(6) 2019 during which the surgeon noted ¿he performed a small bowel anastomosis, repair the mesenteric defects, irrigate and debride the necrotic tissues.¿ it was reported that the patient experienced severe pain, inflammation and bowel injuries.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 5/21/2021.Additional information: a2, d3 date sent to the fda: 5/21/2021.Corrected information: d6a.Corrected b5 narrative: it was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2009.
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Manufacturer Narrative
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Date sent to the fda: 06/01/2021.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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