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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); Scar Tissue (2060); Chills (2191); 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) 2017.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 revision surgery on (b)(6) 2017 and mesh was implanted during which the surgeon noted due to significant adhesions that had to be dissected.The ilioinguinal nerve also had to be divided in order to avoid nerve entrapment syndrome and the spermatic cord had to be dissected.It was reported that the patient underwent removal surgery on an unk date during which the surgeon noted due to separation of the mesh from the repair site and very extensive adhesions, which toon an hour to remove.There were several small swiss cheese type defects along the edge of the mesh and there was an area scarring that was to the lower portion of the previously placed mesh.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite 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: 5/1/2022.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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