Model Number PHSL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
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) 2009 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2019 and mesh was implanted during which the surgeon noted the mesh was appreciated and scarred in significantly and was bundled up.He was not able to appreciate a clear ilioinguinal nerve and suspected that the nerve was contained within the bundle of scar tissue and mesh that was removed.It was reported that the patient underwent inguinal herniorrhaphy on (b)(6) 2022 during which the surgeon noted significant amount of residual mesh and scarring from previous surgery so he dissected out the underlay portion of the previous mesh, opening that it may have ben the source of nerve entrapment.It was reported that the patient experienced an unknown adverse event.Other procedure is captured under separate file.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.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2019.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2022.
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Manufacturer Narrative
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Date sent to the fda: 5/12/2022.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: 08/18/2022.Additional information: a2, b7.Additional b5 narrative: it was reported that the patient experienced pain following surgery.Date sent to the fda: 08/18/2022.Corrected information: d6a.Corrected b5 narrative: it was reported that the patient underwent hernia repair surgery on (b)(6) 2019 and mesh was implanted.
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Search Alerts/Recalls
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