Model Number PHSL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Injury (2348); Not Applicable (3189)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).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) 2018.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2019.
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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) 2010 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2018 during which the surgeon noted upon entering the groin area, it was discovered that the patient had a left indirect inguinal hernia.The mesh was dissected free and approximately ninety percent of the mesh was removed.It was reported that the patient underwent removal surgery on (b)(6) 2019 during which the surgeon noted upon entering the left groin area, the surgeon discovered a lump of mesh.The surgeon used electric cuttery to remove the mesh ball.It was reported that the patient experienced an unknown adverse event.No additional information is provided.
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Manufacturer Narrative
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Date sent to fda: 9/2/2020.Additional information: 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: 02/12/2021.
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Search Alerts/Recalls
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