Model Number PHSL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Pain (1994)
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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) 2013 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2020 during which the surgeon noted a portion of the mesh was exposed and correlated with a collection of purulent fluid.It was reported that the patient experienced infection, abscess, adhesions, intractable and severe chronic pain.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 7/23/2021.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: 10/4/2021.
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Search Alerts/Recalls
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