Model Number PHSL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Scar Tissue (2060); Hernia (2240)
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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) 2012 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 mesh was found to be enveloping the spermatic cord and as found to be very scarred in place.He resected the mesh and a portion of the external oblique.He also performed a ilioinguinal nerve resection.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2019.It was reported that the patient experienced chronic pain, scarring, anxiety, mental anguish and stress.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.(b)(4) submitted for adverse event which occurred on (b)(6) 2017.(b)(4) submitted for adverse event which occurred on (b)(6) 2019.
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Manufacturer Narrative
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Date sent to the fda: 4/5/2022.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: 7/26/2022.
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Search Alerts/Recalls
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