Model Number PHSL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Hernia (2240); Fibrosis (3167); 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.
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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) 2018 and mesh was implanted.It was reported that the patient underwent revision surgery and repair of recurrent right inguinal hernia on (b)(6) 2019 during which the surgeon noted the old mesh appeared to be wadded up medially near the pubic tubercle.Some fibrosis was encountered as well.It was reported that the patient experienced an unknown event.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: (b)(6) 2020.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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Manufacturer Narrative
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Date sent to the fda: 3/11/2021.Additional information: a1, a2, b7.Additional b5 narrative: it was reported that the patient experienced pain and adhesions following surgery.
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Search Alerts/Recalls
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