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Model Number PVPM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Swelling (2091)
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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) 2013 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2014.It was reported that the patient experienced severe pain, infection, and swelling.Other procedure is captured in a separate file.No additional information was provided.
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Manufacturer Narrative
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Date sent to fda: (b)(6) 2020.Additional information: d1, d4, h4.A review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.
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Search Alerts/Recalls
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