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Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); Scar Tissue (2060); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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) 2011 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2013 due to abdominal abscess and adhesions.It was reported that the patient underwent hernia repair surgery, laparotomy with extensive enterolysis and partial small bowel resection on (b)(6) 2014 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2020 during which the surgeon noted dense intra-abdominal adhesions and bowel erosion resulting in small bowel obstruction with subsequent small bowel resection.It was reported that the patient experienced severe pain, inflammation, scarring, bulging, loss of appetite, stress and anxiety.The patient had a previous mesh implanted on (b)(6) 2007 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: 10/24/2022.(b)(4).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) 2013.(b)(4) submitted for adverse event which occurred on (b)(6) 2014.(b)(4) submitted for adverse event which occurred on (b)(6) 2015.(b)(4) submitted for adverse event which occurred on (b)(6) 2020.
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Manufacturer Narrative
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Date sent to the fda: 11/11/2022.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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