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.
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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) 2018 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent incisional hernia repair surgery on (b)(6) 2019 during which the surgeon noted ¿the omentum was adherent to the mesh.He dissected the adhesions and the previously placed mesh was removed.¿ it was reported that the patient experienced severe pain, nausea, diarrhea, chills inflammation, loss of appetite and extreme weight loss.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 08/13/2021.
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Manufacturer Narrative
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Date sent to the fda: 10/10/2021.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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Search Alerts/Recalls
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