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Model Number PVPS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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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) 2017 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2021 during which the surgeon noted upon visualizing the mesh, he dissected free the mesh from the surrounding tissue as much as possible.He sharply excised the mesh and any additional visible suture material was removed as well.It was reported that the patient experienced chronic and acute pain.No additional information was provided.
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Search Alerts/Recalls
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