Catalog Number PHY1015V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Hernia (2240)
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Event Type
Injury
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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.
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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) 2015 and mesh was implanted.It was reported that the patient experienced abdominal pain.It was reported that the patient underwent hernia repair and removal of mesh surgery on (b)(6) 2016 due to infected mesh and recurrent right flank hernia.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 07/06/2021.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: 10/31/2021.
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Search Alerts/Recalls
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