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Model Number PCDJ1 |
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); Obstruction/Occlusion (2422); 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) 2015.Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2018.Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2019.
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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) 2008 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient underwent partial removal surgery of the mesh on (b)(6) 2018.It was reported that the patient underwent removal surgery of the two mesh products on (b)(6) 2019.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.The other procedure is captured in a separate file.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 6/13/2022 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: 5/26/2022.Additional b5 narrative: it was reported that the patient experienced incarcerated ventral hernia with small bowel obstruction, adhesions.
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Search Alerts/Recalls
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