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Model Number PHSL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Granuloma (1876); Nerve Damage (1979); Pain (1994); Scar Tissue (2060)
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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) 2017 and mesh was implanted.It was reported that the patient underwent partial removal surgery and right ilioinguinal neurectomy on (b)(6) 2018 during which the surgeon noted there was a portion of the mesh which was noted to be external into the patient¿s external oblique fascia.They were able to identify the ilioinguinal nerve traveling directly into a large piece of mesh with extensive scar tissue present.The segment of the nerve was resected along with portion of the mesh, which was noted to be external to the external oblique fascia and noted to be very thickened and encasing scar tissue.It was reported that the patient experienced chronic pain, mesh erosion, right ilioinguinal nerve entrapment and either granuloma versus neuroma versus scar tissue over the right groin mesh at the level of the ilioinguinal nerve.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: 12/7/2022 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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Search Alerts/Recalls
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