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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); Hernia (2240); Not Applicable (3189)
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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.
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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) 2010 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2019 during which the surgeon noted a recurrent hernia coming through the previously placed intraperitoneal mesh.There were additional omental adhesions to the mesh.Lysis of adhesion was performed using a combination of sharp and blunt dissection.The mesh was dissected free from the surrounding and adhered abdominal structures and fascia and removed.It was reported that the patient experienced dense adhesions, severe pain, scarring, inflammation, loss of appetite, stress and anxiety.No additional information was provided.
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Manufacturer Narrative
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Date sent to fda: (b)(6) 2020.Additional information: d4, h4.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: 03/11/2021.Additional information: a1, a2, b7.
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Search Alerts/Recalls
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