Catalog Number PVPM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); Decreased Appetite (4569)
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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) 2010 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2016.It was reported that the patient experienced severe pain, inflammation and loss of appetite.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 10/20/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Date sent to the fda: 10/20/2021 corrected information: g1 - manufacturing site name and address; g4 - pma/ 510(k).
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Manufacturer Narrative
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Date sent to the fda: 2/15/2022.
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Search Alerts/Recalls
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