Model Number PVPM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Failure of Implant (1924); Swelling (2091); Hernia (2240)
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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) 2012 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2019 during which the surgeon noted the mesh failed causing a recurrent hernia.It was reported that the patient experienced severe pain and swelling abdomen.No additional information is provided.
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Manufacturer Narrative
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Date sent to the fda: 02/16/2021.
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Manufacturer Narrative
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Date sent to the fda: 4/6/2021.
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Manufacturer Narrative
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Date sent to the fda: 04/12/2021.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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