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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); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Hernia (2240); Weight Changes (2607); Decreased Appetite (4569)
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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.Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2018.Mwr# (b)(4), submitted for adverse event which occurred on unk date.Mwr# (b)(4), submitted for adverse event which occurred on unk date.
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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) 2016 and mesh was implanted.It was reported that the patient underwent ventral hernia repair surgery on (b)(6) 2018 and mesh was implanted.It was reported that the patient underwent revision surgery on an unk date during which the surgeon noted due to hernia recursion and dense adhesions which were removed.It was reported that the patient underwent removal surgery on an unk date during which the surgeon noted the umbilicus had to be removed along with the mesh.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite, loss of umbilicus and extreme weight loss.Other procedure is captured under separate file.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 8/17/2022.It was reported that the patient experienced recurrent ventral hernia and adhesions following surgery.
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Manufacturer Narrative
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Date sent to the fda: 08/29/2022.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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