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Model Number PVPM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Calcium Deposits/Calcification (1758); Inflammation (1932); Pain (1994); Discomfort (2330); Fibrosis (3167)
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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) 2011 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2020.It was reported that the patient experienced severe and chronic pain/ discomfort, inflammation, fibrosis, calcification, nests of interloop adhesions to the bowel, and prominently buckle of mesh that was slightly cephalad to his point of tenderness.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 10/04/2021.
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Manufacturer Narrative
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Date sent to the fda: 11/8/2021.Additional information: a1, a2, b7.
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Search Alerts/Recalls
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