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Model Number PCDN1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Erosion (1750); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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(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 the adverse event which occurred on (b)(6) 2007.(b)(4) submitted for the adverse event which occurred on (b)(6) 2021.
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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) 2007 and mesh was implanted.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2007.It was reported that the patient underwent removal surgery on (b)(6) 2021 during which the surgeon noted the infected mesh had eroded through small bowel and fascia, extensive adhesions and an enterocutaneous fistula.During the surgery, he had to perform extensive lysis of adhesions, a small bowel resection, removal of infected mesh and application of a negative pressure wound vac.It was reported that the patient experienced severe pain, inflammation, stomach problems and stress.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 11/25/2021.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: 3/23/2022.Additional information: a2.
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Search Alerts/Recalls
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