Model Number PCDT1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Necrosis (1971); Hernia (2240)
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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) 2016 and mesh was implanted.It was reported that the patient underwent a revision procedure on (b)(6) 2017 during which the surgeon noted the mesh had ruptured in the center, causing re-herniation and strangulation and resulting necrosis of the small bowel.The surgeon performed an emergent bowel resection and re-anastomosis, resection of mesh and application of wound vac.It was reported that the patient experienced an unknown adverse event.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 03/03/2021.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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Manufacturer Narrative
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Date sent to the fda: 4/19/2022.
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Search Alerts/Recalls
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