Model Number PHSL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); 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) 2014 and mesh was implanted.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2020 during which the surgeon noted ¿the mesh to have pulled away from the pubic tubercle.¿ it was reported that the patient experienced severe pain, stress and anxiety.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 12/27/2021.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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Manufacturer Narrative
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Date sent to the fda: 1/12/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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