Model Number PHSE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)
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Event Type
Injury
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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) 2013 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on(b)(6) 2017 during which the surgeon noted the adhesions to the periumbilical mesh was utilized carefully with sharp dissection.The involved bowel has a compromise of the seromuscular layer.The bowel was repaired and further lysis of adhesions of the omentum to the mesh was performed.The mesh in the periumbilical region was excised.It was reported that the patient experienced a bowel obstruction.No additional information was provided.
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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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Manufacturer Narrative
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Date sent to the fda: 10/28/2022.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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