Model Number PVPM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Obstruction/Occlusion (2422)
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Event Type
Injury
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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) 2014 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2015 and on (b)(6) 2018.It was reported that the patient experienced pain, nausea, diarrhea, chills, and inflammation.The patient had a previous mesh implanted on (b)(6) 2013 which is captured in separate file.No additional information was provided.
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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.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2015.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2018.
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Manufacturer Narrative
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Date sent to the fda: 10/10/2022.Additional b5 narrative: it was reported that the patient had adhesions, small bowel obstruction.
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Manufacturer Narrative
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Date sent to the fda: 10/18/2022.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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