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Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); 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) 2016.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) 2014 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2016 and mesh was implanted.It was reported that the patient underwent removal surgery on an unk date during which the surgeon noted a partial omentectomy was necessary.The majority of the old mesh, which was not invested in the abdominal wall, was removed.It was reported that the patient underwent removal surgery on an unk date during which the surgeon noted extensive adhesions also had to be removed and as part of the process, a portion of the bowel had to be removed.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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